Device product
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Z-0411-2014
Product summary
- Firm
- Ebi, Llc
- Event
- Event 66654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0411-2014
Official wording
Reason: Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Code information: Device listing # D090878 Catalog # LV00407 Lot #184090
Distribution pattern: US Distribution to CA
Derived failure modes
-
Unknown
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.