5.5 STRAIGHT RODS, TI ALLOY 300MM

Additional Manufacturer Narrative

D4: THE REMAINDER OF THE UDI NUMBER IS UNKNOWN BECAUSE THE LOT NUMBER IS NOT AVAILABLE. D10: TWO PEDICLE SCREWS WITH SET SCREWS, UNKNOWN MANUFACTURER FROM PRIOR SURGERY ON UNKNOWN DATE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS DISENGAGEMENT OF THE RODS FROM THE SCREWS AT S1, APPARENT PSEUDARTHROSIS AT L5-S1, AND LIMITED FUSION AT OTHER LUMBAR LEVELS. THE POST-OPERATIVE DIAGNOSIS INCLUDED HARDWARE FAILURE WITH FRACTURE OF THE LEFT L1 SCREW AND DISLODGEMENT OF THE RODS BILATERALLY AT S1. THIS IS REPORT ONE OF THREE FOR THIS EVENT.