CLOSURE TOP
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 3012447612-2026-00168 · MDR key 25739480
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Highridge Medical, LlcModel number
NACatalog number
3301-1
Lot number
ABN
Product problems
- Material Deformation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A REVISION SURGERY TO ADDRESS ADJACENT SEGMENT DISEASE, EIGHT PATHFINDER CLOSURE TOP INNER HEXAGONS WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURAL IMPACT, ASIDE FROM A ROUGHLY 30 MINUTE DELAY, AND OTHER CLOSURE TOPS WERE AVAILABLE TO COMPLETE THE CASE.THIS IS REPORT FOUR OF EIGHT FOR THIS EVENT.
Additional Manufacturer Narrative
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 3012447612-2026-00165 THROUGH 3012447612-2026-00172.