Spine Instruments 03.52.10.0420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971202665), received between Jun 13, 2019 and Jun 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2019Break; Break

  DURING THE SPINE MIS SURGERY IT WAS DIFFICULT TO DISENGAGE THE ROD HOLDER FROM THE ROD (TIP BLOCKED ON THE ROD). THE SURGEON TRIED TO PULL IT OUT WITHOUT SUCCESS. HE USED ALSO AN HAMMER TO FORCE THE PART AND THE INSTRUMENT BROKE. IT WAS NOT POSSIBLE TO DISASSEMBLE THE INSTRUMENT TIP FROM THE ROD SO THE SURGEON HAD TO PERFORM AN ADDITIONAL CUT TO REMOVE THE INSTRUMENT PART. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT 1 HOUR OF DELAY EXPERIENCED IN THE SURGERY AND AN ADDITIONAL CUT NECESSARY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8695293 ↗