Spine Instruments 03.30.10.0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040798396), received between Nov 19, 2018 and Apr 5, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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.

• MalfunctionApr 5, 2019Material Fragmentation; Material Fragmentation

  DURING THE VERTEBRA TAPPING, IN THE ANTERIOR SURGERY, THE TIP OF THE INSTRUMENT BROKE OFF. THE BROKEN FRAGMENT REMAINED IN SITU AND FOR THIS THE SURGEON WAS ABLE TO INSERT ONLY 3 BONE SCREWS. 9 DAYS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A SECOND SURGERY TO INSERT THE POSTERIOR STABILIZATION IMPLANTS. THE SURGERY WAS COMPLETED ANYWAY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486482 ↗
• MalfunctionMar 12, 2019Fracture; Fracture

  WHEN TAPPING THE PATHWAY FOR THE FIRST SCREW, THE TIP OF THE TAP BROKE OFF. ACCORDING TO THE SURGEON NO EXCESSIVE LATERAL FORCES WERE APPLIED. THE TIP WAS REMOVED WITH THE HELP OF A KOCHER FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412845 ↗
• MalfunctionNov 19, 2018Fracture; Fracture

  WHEN USING THE TAP STRAIGHT IN THE USUAL MANNER TO PREPARE THE HOLE FOR THE SCREW, THE TIP OF THE TAP BROKE OFF. THE BROKEN PIECE REMAINED IN THE PATIENT BUT TO DATE THERE WAS NO NECESSITY TO DO ANOTHER SURGERY AND THERE WAS NO DELAY IN THE COURSE OF THE CURRENT SURGERY AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8084541 ↗