Spine Instruments 03.52.10.0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630971202542), received between Apr 17, 2019 and Nov 19, 2025 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  DURING SPINAL MIS SURGERY, THE TIP OF A SCREWDRIVER BROKE WHILE IMPLANTING THE THIRD PEDICLE SCREW (SURGICAL TECNIQUE FOLLOWED, AWL, WIRE AND TAP USED), CAUSING SLIGHT DAMAGE TO THE SCREW TULIP AND MAKING THE INSTRUMENT UNUSABLE. THE SURGERY WAS NOT AFFECTED, AS A SPARE SCREWDRIVER WAS AVAILABLE, AND NO HARM OCCURRED TO THE PATIENT. THE OPERATED LEVELS WERE L4-L5. THE PATIENT'S BONE QUALITY WAS GOOD, WITH NO SIGNS OF OSTEOPOROSIS OR ABNORMAL DENSITY. A NEW SCREW (SIZE UNKNOWN) WAS OPENED AND USED BECAUSE THE DAMAGED SCREW SHOWED MINOR DENTING, EVEN THOUGH NO FRAGMENT REMAINED ATTACHED TO THE IMPLANT. THE SURGEON PERFORMED A MINI-OPEN APPROACH (CUT EXTENSION), USED A PEDICLE AWL AND PEDICLE PROBE LUMBAR, TO POSITION THE NEW SCREW. NO PART OF THE INSTRUMENT REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591140 ↗
• MalfunctionSep 12, 2023Solder Joint Fracture; Solder Joint Fracture

  DURING SURGERY THE TIP OF THE MUST PEDICLE SCREWDRIVER BROKE. THE SURGERY WAS DELAYED OF 3 HOURS IN ORDER TO REMOVE THE PEDICLE SCREW BECAUSE THE INSTRUMENT TIP WAS STUCK IN THE TULIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729257 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  THE PATIENT UNDERGONE L4-L5 SURGERY, THAT WAS A REVISION OF COMPETITOR'S IMPLANTS. THE 6.5MM COMPETITOR'S SCREW IN L4 LEFT WAS REMOVED AND TAPPING WITH MUST SOLID TAP WAS PERFORMED (7MM -> 8MM -> 10MM) IN ORDER TO INSERT THE PEDICLE SCREW 10X50MM. DURING THE INSERTION, THE TIP OF TWO MUST PEDICLE SCREWDRIVER - MIS HYBRID WERE FRACTURED. THE TWO AVAILABLE BONE SCREWDRIVERS WERE USED TO REMOVE THE SCREW, BUT BOTH WERE FRACTURED. OTHER SCREWDRIVERS WERE NOT AVAILABLE AND THE THREAD OF SCREW HEAD WAS DAMAGED AND FOR THIS REASON, IT WAS NOT POSSIBLE TO INSERT THE SET SCREW IN ORDER TO FIX THE ROD AND REMOVE THE PEDICLE SCREW. L4-L5 SCREWS ON THE RIGHT SIDE WERE IMPLANTED. THE PEDICLE SCREW ON THE LEFT SIDE WAS LEFT IN THE BODY WITHOUT SET SCREW. THE SURGERY WAS COMPLETED WITH 30MIN DELAY TIME BECAUSE OF THE REPORTED ISSUES. THE BONE WAS REPORTED TO BE A LITTLE FRAGILE. THE REVISION SURGERY WAS CONDUCTED ON THE 8TH OF AUGUST. THE PEDICLE SCREW WAS REMOVED, AND NEW SCREW (REF. 03.50.092) WAS REPLACED WITH IT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17661081 ↗
• MalfunctionJun 14, 2019Material Fragmentation; Material Fragmentation

  TLIF SURGERY WAS PERFORMED AT L4-S1. WHEN THE SURGEON INSERTED THE PEDICLE SCREW AT RIGHT SIDE OF L5, HE FELT ABNORMAL FEELINGS. HE DISCOVERED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. THE BROKEN PIECES OF THE SCREW DRIVER REMAINED IN THE PEDICLE SCREW TULIP. THE SURGERY WAS FINISHED WITHOUT RETRIEVING BROKEN PIECES. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. THE PATIENT BONE WAS VERY HARD, SO THE TAPS WERE USED BEFORE INSERTING THE PEDICLE SCREW. MIS TECHNIQUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8699970 ↗
• MalfunctionApr 17, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY SPINE SURGERY AND WHILE INSERTING A PEDICLE SCREW INTO THE RIGHT L-3 PEDICLE, AN AUDIBLE SOUND WAS HEARD AND THE SCREW COULD NO LONGER BE ADVANCED. UPON REMOVING THE DRIVER, IT WAS DISCOVERED THAT THE TIP OF THE DRIVER HAD BROKEN OFF INSIDE OF THE SCREW. SOME FRAGMENTS OF THE BROKEN TIP WERE RECOVERED BUT A PORTION OF THE TIP COULD NOT BE RETRIEVED. THE SURGEON REMOVED THE SCREW AND INSERTED ANOTHER SCREW WITHOUT INCIDENT AND THERE WAS MINIMAL DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8522862 ↗