5.5 STRAIGHT RODS, TI ALLOY 300MM

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 THREE OF THREE FOR THIS EVENT.

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. REFERENCE REPORTS 3012447612-2026-00186 THROUGH 3012447612-2026-00188.