Device product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
Z-2217-2020
Product summary
- Event
- Event 85613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3235 total
- Official record key
device-enforcement:Z-2217-2020
Official wording
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Code information: UDI: (01)00887868324451; Lot Numbers: C19H0010 C19I0008 C19J0012 C19K0008 C20A0005 SBM108406 SBM118988 SBM122122
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.