Device product
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.
Z-1089-2015
Product summary
- Event
- Event 70376
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-1089-2015
Official wording
Reason: The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
Code information: LOT Numbers: L561968 and L570545 Product Code: 7703-1600
Distribution pattern: Distributed to TX, OH, NE and NY.
Derived failure modes
-
Unknown
The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.