Device product
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Z-1737-2013
Product summary
- Event
- Event 64989
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 rods
- Official record key
device-enforcement:Z-1737-2013
Official wording
Reason: One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Code information: Lot Number: 002876-007R
Distribution pattern: USA Nationwide Distribution including the state of TX
Derived failure modes
-
Unknown
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.