XIA 3 48231326Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327265279), received between Feb 24, 2016 and Mar 15, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2018Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT TOO MUCH TORQUE WAS APPLIED TO CLOSED HEAD ILIAC SCREWDRIVERS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7342530 ↗
• MalfunctionMar 15, 2018Fracture; Fracture; Material Torqued

  IT WAS REPORTED THAT TOO MUCH TORQUE WAS APPLIED TO CLOSED HEAD ILIAC SCREWDRIVERS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7342529 ↗
• MalfunctionMar 15, 2018Fracture; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT TOO MUCH TORQUE WAS APPLIED TO CLOSED HEAD ILIAC SCREWDRIVERS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7342444 ↗
• MalfunctionJan 29, 2018Break; Fracture; Fracture

  IT AS REPORTED THAT THE SCREWDRIVER TIP BROKE UPON SCREW INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224302 ↗
• MalfunctionJan 17, 2018Break

  IT WAS REPORTED THAT; SURGEON HAD SOME NEGATIVE EXPERIENCES WITH THE SCREWDRIVER AND THE POLYAXIAL CLOSED HEAD SCREWS IN A RECENT SURGERY. FOR THE CLOSED HEAD POLYAXIAL SCREW, HE EXPERIENCED A STRIPPED SET SCREW DURING FINAL TIGHTENING. FOR THE SCREWDRIVER HE EXPERIENCED STRIPPING AND BREAKING OF THE T25 TORX DRIVE GEOMETRY DURING SCREW INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199460 ↗
• MalfunctionJun 30, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE IMPLANTING 8.5X80 SCREW W THANDLE ATTACHED TO SCREWDRIVER. GOT 3/4 WAY IN AND HEAD SNAPPED/BROKE RESULTING IN BREAKING THE HEAD OF SCREW. HEAD OF SCREW WAS RETRIEVED FROM PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681581 ↗
• MalfunctionJan 4, 2017Material Deformation; Break; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT AS SURGEON WAS ADVANCING PEDICLE SCREW, TOO MUCH TORQUE WAS APPLIED THUS SCREWDRIVER THREADS BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6221263 ↗
• MalfunctionJul 5, 2016Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT; THE SECOND REVISION SURGERY WAS PERFORMED DUE TO THE ROD BREAKAGE. THE LEFT AND RIGHT OF THE ROD WERE BROKE IN TWO LEVELS (LEFT: L4/5 AND L3/4, RIGHT: L5/S1 AND L4/5). DURING THE REVISION SURGERY, THE SURGEON TRIED TO REMOVE THE CLOSED POLYAXIAL SCREW ON LEFT S2AI. BUT THE SCREW WAS NOT ABLE TO REMOVED AND THE TIP OF THE DRIVERS WAS DEFORMED. THE SCREW SHAFT WAS REMAINED. THIS EVENT IS RELATED TO (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5769993 ↗
• MalfunctionJun 24, 2016Break; Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED: SURGEON WAS USING SCREWDRIVER AND STRIPPED THE THREADS ON THE DRIVER RENDERING IT USELESS, REP WAS ABLE TO SOLVE THE PROBLEM BY UTILIZING SECONDARY BACKUP TO WHICH WAS BROKEN AS WELL (THIS SURGEON BREAKS THESE ABOUT EVERY TWO WEEKS) THE REPLACEMENT DEVICE USED WAS THE BACKUP AND THE SCREWS WERE NOT LEFT DAMAGED AND THE CASE WAS ABLE TO CLOSE UNIMPEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5749017 ↗
• MalfunctionJun 24, 2016Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT; SURGEON WAS USING SCREWDRIVER AND STRIPPED THE THREADS ON THE DRIVER RENDERING IT USELESS, REP WAS ABLE TO SOLVE THE PROBLEM BY UTILIZING SECONDARY BACKUP TO WHICH WAS BROKEN AS WELL (THIS SURGEON BREAKS THESE ABOUT EVERY TWO WEEKS) THE REPLACEMENT DEVICE USED WAS THE BACKUP AND THE SCREWS WERE NOT LEFT DAMAGED AND THE CASE WAS ABLE TO CLOSE UNIMPEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5749009 ↗
• MalfunctionMar 14, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP ON THE SCREWDRIVER FOR CLOSED HEAD SCREWS SHEARED OFF FROM SCREWDRIVER UPON INSERTION OF SCREW INTO THE BONE. SCREW AND TIP WERE LEFT IN PLACE AND USED IN CONSTRUCT. THE TAP WAS BROKEN IN BONE UPON TAPPING THE BONE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5499063 ↗
• MalfunctionFeb 24, 2016Material Deformation; Break; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ADVANCING PEDICLE SCREW INTO THE VERTEBRAL BODY, THE SCREWDRIVER STRIPPED AND THE THREADS BROKE. THIS WAS KNOWN DUE TO THE FACT THAT THE SURGEON PLACES EXTREMELY LARGE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5458196 ↗