Device product
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Z-1869-2013
Product summary
- Event
- Event 64987
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 caddies
- Official record key
device-enforcement:Z-1869-2013
Official wording
Reason: Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Code information: 31176, 018652, 018645R, 42011
Distribution pattern: US distribution in states of: CO, DC, MA and TX.
Derived failure modes
-
Unknown
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.