Events

Safety Alert for T-PAL, Technique Guide

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

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
    2014-08-01
  • Event Date Posted
    2014-08-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140801a.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 t-pal, technique guide medical device manufacturer, synthes gmbh, has issued a medical device labeling update concerning its t-pal, technique guide [part no.: 036.001.088; updated revision ad; outdated revisions: aa, ab, ac]. the manufacturer updated the t-pal technique guide (pn 036.001.088) on page 19, 21 and 47 to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). faulty handling of the t-pal applicator instrument potentially contributes to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-317 and 03.812.507-517). according to the manufacturer, if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0o position. this rigid position is necessary for insertion; in the pivoting position, the assembly cannot be properly advanced into the disc space. furthermore, loss of rigidity during advancement of the trial (implant) into disc space could result in loss of tactile control by the surgeon. this failure is known to have resulted in a significant surgery delay and minor vascular injury. depending upon the stage of surgery, if the failure were to occur the potential harms in a worst case scenario could be: serious surgical delay; injuries to the spinal cord or cauda equina, meninges, and/or spinal nerve; damage to soft tissue; vascular damage. the manufacturer has not had any complaints of the above-mentioned events to date. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.

Device

T-PAL, Technique Guide
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes T-PAL, Technique Guide
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH