Device product
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0367-2013
Product summary
- Firm
- NuVasive Inc
- Event
- Event 52634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 units total
- Official record key
device-enforcement:Z-0367-2013
Official wording
Reason: The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information: Batch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400
Distribution pattern: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Derived failure modes
-
Unknown
The tulip portion of the screw assembly can disengage from the shank after implantation.