Device product
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Z-0162-2016
Product summary
- Firm
- Materialise N.V.
- Event
- Event 72425
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0162-2016
Official wording
Reason: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Code information: 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
Distribution pattern: Distributed in MI, ID, TX, and in France.
Derived failure modes
-
Unknown
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.