Events

Safety Alert for Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) / KLS Martin Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06)

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

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
    2011-08-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804b.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
    Field safety notice: use of brainlab skull reference base in combination with kls martin cross-drive screws brainlab ag has issued a product notification regarding the use of the brainlab disposable self-tapping screw 1.5 x 6mm (art. no. 52128) / kls martin cross-drive screw 1.5x6mm (art. no. 25-678-06) in combination with the brainlab skull reference base (art. no. 52121b, 52129, 52129a). applying too much torque or tensile force to the head of the screw during insertion and fixation of the skull reference base may cause the screw head to deform or to shear off. in such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient’s skull bone. depending on the used skull reference base version, brainlab ag will provide customers with updated instructions for use regarding safe use of the skull reference array kit. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) / KLS Martin Cross-Drive Screw ...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [4 Aug 2011] Use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG