Device product
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Z-1479-2015
Product summary
- Event
- Event 70488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 devices
- Official record key
device-enforcement:Z-1479-2015
Official wording
Reason: The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Code information: Revision E
Distribution pattern: US Nationwide Distribution in the states of TX, KS, CO, and MA
Derived failure modes
-
Unknown
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.