N/A 9569313Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074549712), received between Nov 24, 2019 and May 27, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, 13MM DIRECT LATERAL INTERBODY FUSION (DLIF) HOLDING PIN BROKE UPON INSERTION TO VERTEBRAL BODY AFTER ENCOUNTERING PREVIOUSLY PLACED PEDICLE SCREW. A 10MM PIECE (APPROXIMATE) WAS BROKEN OFF IN THE VERTEBRAL BODY AND COULD NOT BE REMOVED. THE PIN WAS BROKEN WHEN IT HIT THE PEDICLE SCREW. THE LEVELS TREATED WERE L4/5. PROCEDURE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION/POSTERIOR SPINAL FUSION. THERE WAS NO REVISION SURGERY PLANNED TO RETRIEVE THE BROKEN PIECE. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22085396 ↗
• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING LEFT SIDED L4-5 DLIF. IT WAS REPORTED THAT THE END OF THE STABILITY PIN BROKE OFF INTO HARD SCLEROTIC BONE IN L5.BROKEN FRAGMENTS REMAINS INSIDE THE PATIENT. NO SURGERY SCHEDULED TO EXTRACT FRAGMENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21502002 ↗
• InjuryNov 24, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L3-L4-L5 DUE TO LUMBAR CANAL STENOSIS AND SPONDYLOLISTHESIS AT THESE LEVELS. THE PATIENT HAD A VERY HARD BONE. INTRA-OP, THE TIP OF THE PIN BROKE WHEN THE ALLEGED PIN WAS BEING INSERTED INTO L4 VERTEBRAL BODY. ANOTHER PIN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE BROKEN PART WAS TRIED TO BE REMOVED BUT COULD NOT BE REMOVED. HENCE, WOUND CLOSURE WAS PERFORMED, WITH THE FRAGMENT OF THE BROKEN TIP REMAINING IN THE VERTEBRAL BODY. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED YET.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9367273 ↗