Device product
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Z-0848-2018
Product summary
- Event
- Event 79072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130 units total
- Official record key
device-enforcement:Z-0848-2018
Official wording
Reason: Potential for Intra-operative breakage of driver tips
Code information: Product code: 287804101G Lot number: 052316-A R, 121416-A R
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Potential for Intra-operative breakage of driver tips