Device product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - 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-2215-2020
Product summary
- Event
- Event 85613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3235 total
- Official record key
device-enforcement:Z-2215-2020
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)00887868324437; Lot Numbers: C19G0006 C19H0009 C19I0006 C19J0008 C19K0006 C19L0017 SBM108404 SBM118986 SBM121778
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.