Spine Instruments 03.52.10.0723Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345704320), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 16, 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.

• MalfunctionOct 29, 2021Defective Component; Separation Failure

  DURING THE PRIMARY SPINE SURGERY, THE SURGEON WAS NOT ABLE TO LOAD THE MUST LT SCREW TO THE MODULAR SCREWDRIVER. IT WAS UNCLEAR IF THE MODULAR SCREWDRIVER WAS BROKEN OR ASSEMBLED INCORRECTLY. THE SURGEON USED INSTEAD THE QUICK SCREWDRIVER AND LOADED CORRECTLY THE MUST LT SCREW. AFTER INSERTING THE QUICK SCREWDRIVER (WITH THE ATTACHED MUST LT SCREW), THE SURGEON WAS NOT ABLE TO REMOVE THE SCREWDRIVER FROM THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A COMPETITOR SCREW SYSTEM WITH 30 MINUTES OF DELAY IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719411 ↗