Events

Safety Alert for Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-06-18
  • Event Date Posted
    2013-06-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130618.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes reduction instrument for spondylolisthesis, standard, for matrix 5.5 medical device manufacturer, synthes issued a medical device safety alert concerning reduction instrument for spondylolisthesis, standard, for matrix 5.5 (part number: 03.632.008; lot numbers: all). synthes received complaints that during spine surgery using the reduction instrument for spondylolisthesis, standard, for matrix 5.5 (03.632.008), the reduction insert broke and pieces broke off. once the reduction insert breaks, the instrument does not function as required. synthes explained that in a hypothetical worst case scenario, if the insert breaks and fragment(s) are retained, they may not be retrieved. additional operative time may be required to attempt retrieval and x-ray may not be effective to confirm that all fragments have been retrieved because the fragments are radiolucent. if fragments are retained there is a potential for an unfavorable response to the foreign material (chemical, biological or physical) within the body (including implant-related metal debris, wear particles, non-biocompatible materials) to occur which may trigger a localised reaction. the patient may be symptomatic requiring treatment and non-surgical treatment will not be effective as the disease progresses requiring revision surgery or reoperation. if treated on time, no permanent impairment is expected. according to the manufacturer, misassembly of the instrument in the operating room is a probable root cause of this safety issue. synthes has decided to remove the product from the market. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 jun 2013.

Device

Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5
  • Manufacturer
    Synthes

Manufacturer

Synthes