Device product
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
Z-0193-2018
Product summary
- Event
- Event 78501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1142 units
- Official record key
device-enforcement:Z-0193-2018
Official wording
Reason: The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.
Code information: Lots: 17041 and 17272
Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
Derived failure modes
-
Unknown
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.