Device product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Z-2732-2024
Product summary
- Event
- Event 95114
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit (OUS only)
- Official record key
device-enforcement:Z-2732-2024
Official wording
Reason: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Code information: Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Distribution pattern: International distribution to the country of Australia.
Derived failure modes
-
Unknown
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.