DUAL TO QUAD LEAD SHANK 7.1MM BALL 7.5MM X 45MM
Received Jul 21, 2026 · Event occurred Jun 20, 2026
Report 3012447612-2026-00193 · MDR key 25896643
Device
Generic name
Appliance, Fixation, Spinal Interlaminal
Manufacturer
Highridge Medical, LlcModel number
NACatalog number
LS-SC7E7545
Lot number
NI
Product problems
- Detachment of Device or Device Component
Patient
69 YR · Male
- Insufficient Information
Narrative
Additional Manufacturer Narrative
D10: ROD X2, CLOSURE TOPS X6. 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 3012447612-2026-00190 THROUGH 3012447612-2026-00199.
Description of Event or Problem
IT WAS REPORTED THAT TWO DAYS AFTER A LINESIDER CONSTRUCT WAS INSTRUMENTED AT L3-5, THE PATIENT FELT A POP IN HIS BACK AND A FOLLOW-UP MRI FOUND THE TULIP HAD DETACHED FROM THE SCREW SHANK AT LEFT L3. A REVISION SURGERY WAS PERFORMED TO REPLACE THE SCREW. DURING THE REVISION, THE TULIPS DETACHED FROM THE SHAFTS OF FOUR MORE SCREWS. THE FULL CONSTRUCT WAS REMOVED AND REPLACED WITH COMPETITIVE PRODUCT. THIS IS REPORT FOUR OF TEN FOR THIS EVENT.