Spine Instruments 03.51.10.0222Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630971230767), received between Nov 20, 2018 and Feb 28, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2020Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON PLACED THE LEFT L5 SCREW, THE SURGEON DECIDED THAT THE DISC SPACE WAS SO COLLAPSED THAT HE NEEDED TO REMOVE IT. THE SCREW HEAD LOCKED AND STUCK AN ANGLE THAT THE PLAIN SCREWDRIVER COULDN'T ENGAGE. THE SURGEON THEN TRIED THE CANNULATED DRIVER THAT SCREWS ON, UPON TRYING TO TURN OUT, THE SCREW THE TIP OF THE CANNULATED SCREWDRIVER BROKE OFF INSIDE THE SCREW. THE SURGEON THEN ATTACHED A CUT PIECE OF ROD AND TIGHTENED IT TO "HELICOPTER" THE SCREW OUT WITH VICE GRIPS. THE AGENT HAD EXTRA SCREWDRIVERS IN THE SET AND THE SURGEON WAS ABLE TO USE THEM. NO FRAGMENTS FELL INTO THE PATIENT. THIS CAME FROM A LOANER SET. THERE WAS AN HOUR LONG DELAY IN THE CASE AND ADDITIONAL ANESTHESIA WAS ADMINISTERED AND RE-DOSING OF ANTIBIOTICS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 9768913 ↗
• InjuryJan 9, 2020Material Fragmentation; Material Fragmentation

  REVISION SURGERY WAS PERFORMED AT L1-S2AI (MIS:L1/2, OPEN:L3/S2AI). THE COMPETITOR'S 8.5MM DIAMETER PEDICLE SCREWS WERE USED FOR THE PRIMARY SURGERY AT L3-L5 AND REPLACED WITH THE 9MM DIAMETER MUST PEDICLE SCREWS. WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW INTO THE PEDICLE SCREW HEAD AT LEFT SIDE OF L4 WITH THE MUST PEDICLE SCREWDRIVER, THE SURGEON FELT THE ABONOMAL FEELINGS, SO THE SURGEON CHECKED AND DISCOVERED THE TIP OF THE MUST PEDICLE SCREWDRIVER WAS BROKEN. THE BROKEN PIECES OF THE SCREW DRIVER WERE REMAINED IN THE PEDICLE SCREW TULIP. IT WAS NOT ABLE TO RETRIEVE. WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW INTO THE PEDICLE SCREW HEAD AT RIGHT SIDE OF L5 WITH THE POLYAXIAL REDUCTION PEDICLE SCREWDRIVER, THE TIP OF THE POLYAXIAL REDUCTION PEDICLE SCREWDRIVER WAS ALSO BROKEN. THE SURGEON WAS ABLE TO REMOVE THE PEDICLE SCREW BECAUSE IT WAS BEFORE THE SURGEON INSERTED THE PEDICLE SCREW INTO THE PROPER POSITION. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 40 MINUTES. TOTAL SURGERY TIME WAS ABOUT 180 MINS. NO TAPPING WAS PERFORMED. THE SURGEON EXPRESSED OPINIONS THAT THEY SEEM TO HAVE STRUCTURAL ISSUES BECAUSE 2 SCREW DRIVERS BROKE AT THE SAME TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568225 ↗
• MalfunctionApr 18, 2019Material Fragmentation; Material Fragmentation

  INSTRUMENT TIP BREAKAGE DURING SPINAL FIXATION SURGERY L2/L5 PERFORMED WITH MYSPINE MC. THE TAP HAS BEEN USED. A PARTIAL BROKEN PIECE WAS ABLE TO RETRIEVE, BUT SOME WERE REMAINED ON THE PEDICLE SCREW HEAD. THEY WERE NOT ABLE TO RETRIEVE, SO THE SURGEON DECIDED TO FIX THE PEDICLE SCREWS REMAINING SOME BROKEN PIECES. AT THAT TIME SINCE THE POLYAXIAL PEDICLE SCREW HEAD WAS NOT ABLE TO MOVE SMOOTHLY, THE SURGEON HAD TO REPLACE 2 RODS WITH NEW ONES. THE PEDICLE SCREW HEAD MOVEMENT ANGULAR WAS RESTRICTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527545 ↗
• MalfunctionNov 20, 2018Fracture; Fracture

  [LUMBAR FIXATION L4 - L5] DURING THE INSERTION OF A SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE OPERATION WAS CONTINUED NORMALLY WITH ANOTHER SCREWDRIVER AND IT WAS SUCCESSFULLY FINISHED WITHOUT ANY DELAY OR ANY ADDITIONAL PROBLEMS. SCREW INVOLVED: 7MM WIDE AND 45MM LONG. THE TAP WAS USED. BONE QUALITY: NORMAL. THE BROKEN TIP WAS RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8089809 ↗