Device product
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Z-0896-2013
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 64265
- Status
- Terminated
- Classification
- Class II
- Quantity
- 565 total (287 PN 52-6800 and 278 PN 52- 6700)
- Official record key
device-enforcement:Z-0896-2013
Official wording
Reason: There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Code information: Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
Distribution pattern: Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Derived failure modes
-
Unknown
There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.