N/A 6642002Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169492455), received between Oct 12, 2020 and Jan 5, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS EXPERIENCED AN ISSUE IN WHICH THE SET SCREW BREAKOFF PIECE STUCK ON THE DRIVERS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENTS BREAKAGE OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE/ THERAPY INVOLVED WAS ANTERIOR LUMBAR INTERBODY FUSION THERAPY TO L4/5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954525 ↗
• MalfunctionJun 4, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE DRIVER SET SCREW RETAINING DEVICE WOULD NOT HOLD THE SET SCREW. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138489 ↗
• MalfunctionApr 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C6-7 PRESTIGE LP ARTHROPLASTY AT C6-7 LEVELS AND ROUTINE LUMBAR FUSION AT L4-5 LEVELS. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS CERVICAL STENOSIS, ONE LEVEL AT C6-7. IT WAS REPORTED THAT THE DEVICES WERE BROKEN INTER OPERATIVELY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE NAV DRIVERS WERE SENT BACK BECAUSE THE CANNULATIONS ARE RUSTY INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917019 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450872 ↗
• MalfunctionFeb 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING AN INSTRUMENT TO BE USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT TIP OF SCREWDRIVER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341354 ↗
• MalfunctionFeb 8, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS DAMAGED, WITH THE TIP OF THE DRIVER BENT AND BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340463 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING DRIVERS, ROD INSERTER, REDUCER, PEDICLE MARKER, AND A PROBE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320686 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DISTAL TIP OF DRIVER IS BROKEN OFF, WILL NOT RETAIN SET SCREW THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BROKEN DRIVER WAS IDENTIFIED DURING ROUTINE SET INSPECTION. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289849 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN AN UNKNOWN SP INAL THERAPY. IT WAS REPORTED THAT THE DEVICE WOULD NOT BE REMOVED FROM THE DRIVER WITHOUT LOTS OF FORCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289664 ↗
• MalfunctionDec 4, 2024Break; Degraded; Break; Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE BOTH SET SCREW DRIVERS WERE BROKEN AND HAVE WORN OUT TIPS AND WOULD NOT PROPERLY FIT INTO THE SET SCREWS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840735 ↗
• MalfunctionDec 4, 2024Break; Degraded; Break; Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE BOTH SET SCREW DRIVERS WERE BROKEN AND HAVE WORN OUT TIPS AND WOULD NOT PROPERLY FIT INTO THE SET SCREWS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840722 ↗
• MalfunctionNov 19, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20720785 ↗
• MalfunctionJul 16, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING SERVICING IT WAS NOTICED THAT THE DRIVER DOES NOT ATTACH TO THE SET SCREW, THE LATCH OF LID WAS DAMAGED, THE SLEEVE THAT SWITCHES THE HANDLE FROM FORWARD TO REVERSE WAS SEIZING UP AND THE DRIVER WAS STRIPPED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749164 ↗
• MalfunctionMay 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370677 ↗
• MalfunctionApr 26, 2024Break; Break

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SET SCREW RETAINING DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. DRIVER WAS NOT WORKING AND WOULD NOT RETAIN SET SCREW. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE SELF RETAINING SET SCREW DRIVER IS NO LONGER RETAINING A SET SCREW AND IT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195059 ↗
• MalfunctionSep 6, 2022Mechanics Altered; Mechanics Altered

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L5/S POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED BY THE L5 SEPARATION SLIP. IT WAS REPORTED THAT, ALTHOUGH THE SET SCREW WAS INSERTED INTO THE SACRAL BONE, THE SET SCREW DID NOT COME OFF AND WAS REPLACED WITH A DIFFERENT SCREWDRIVER. THE SET SCREW COULD NOT COME OFF, EVEN THOUGH THE NURSE WAS ASKED TO REMOVE IT. THE PROCEDURE WAS CONTINUED BY REPLACING THE SET SCREWDRIVER. THE SETSCREW COULD NOT BE REMOVED FROM THE DRIVER¿S TIP AFTER THE FINAL TIGHTENING. AFTER THE BREAK-OFF OF THE SET SCREW ON THE LEFT S1, THE BROKEN-OFF PIECE DID NOT COME OFF FROM THE TIP OF THE SCREWDRIVER. THE FINAL CONCLUSION WAS COMPLETED WITHOUT ANY PROBLEMS. THE PROCEDURE OR TECHNIQUE PERFORMED WAS L5/SPLIF WITH L5 SEPARATION SLIP. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE STATUS OF PATIENT WAS MENTIONED AS ALIVE ¿ NO INJURY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360352 ↗
• MalfunctionJul 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH POSTERIOR FUSION THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. SET SCREW WON¿T COME OFF TIP OF THE DRIVER. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118203 ↗
• MalfunctionJul 4, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4/5 VERTEBRAL CANAL STENOSIS. IT WAS REPORTED THAT THE SET SCREW WAS ATTACHED TO THE SET SCREW RETAINING DRIVER AND FINAL TIGHTENING WAS PERFORMED. PIECE OF THE SET SCREW THREADING WAS STUCK TO THE SET SCREW RETAINING DRIVER AND COULD NOT BE REMOVED. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14904116 ↗
• MalfunctionApr 25, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT T11 - L4 FIXATION SPINAL THERAPY FOR OSTEOMYELITIS. IT WAS REPORTED THAT TOWARDS THE END OF THE FINAL TIGHTENING THE SET SCREWS BECAME DIFFICULT TO REMOVE FROM INSERTER. NO FURTHER COM PLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DRIVERS WERE DEFORMED. THE REPORTED DRIVERS CAME IN CONTACT WITH PATIENT. LEVELS IMPLANTED WAS T11 - L4 FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191789 ↗
• MalfunctionApr 25, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT T11 - L4 FIXATION SPINAL THERAPY FOR OSTEOMYELITIS. IT WAS REPORTED THAT TOWARDS THE END OF THE FINAL TIGHTENING THE SET SCREWS BECAME DIFFICULT TO REMOVE FROM INSERTER. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DRIVERS WERE DEFORMED. THE REPORTED DRIVERS CAME IN CONTACT WITH PATIENT. LEVELS IMPLANTED WAS T11 - L4 FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191786 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4/5 VERTEBRAL CANAL STENOSIS. IT WAS REPORTED THAT THE SET SCREW WAS ATTACHED TO THE SET SCREW RETAINING DRIVER AND FINAL TIGHTENING WAS PERFORMED. PIECE OF THE SET SCREW THREADING WAS STUCK TO THE SET SCREW RETAINING DRIVER AND COULD NOT BE REMOVED. THE DRIVER TIPS WERE DEFORMED. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575824 ↗
• MalfunctionFeb 21, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4/5 VERTEBRAL CANAL STENOSIS. IT WAS REPORTED THAT THE SET SCREW WAS ATTACHED TO THE SET SCREW RETAINING DRIVER AND FINAL TIGHTENING WAS PERFORMED. PIECE OF THE SET SCREW THREADING WAS STUCK TO THE SET SCREW RETAINING DRIVER AND COULD NOT BE REMOVED. THE DRIVER TIPS WERE DEFORMED. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567797 ↗
• MalfunctionJan 19, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT WITH UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DISTAL TIP OF THE DRIVER WAS BROKEN. IT WAS MENTIONED THAT, IT IS NOT EVIDENT THAT IT WAS BROKEN DURING THE PROCEDURE, IT IS POSSIBLE IT WAS BROKEN BEFOREHAND. THERE WAS NO EVIDENCE OF ANY PART OF THE BROKEN DRIVER REMAINING IN PATIENT AFTER THOROUGH INVESTIGATION BY SURGEON. IT WAS MENTIONED THAT THE PATIENT HAD NO COMPLICATIONS AT THIS TIME AND NO ADVERSE EVENTS REPORTED. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 2021-JAN-05_E1: IT WAS CONFIRMED THAT THE EVENT WAS HAPPENED DURING INTRA-OP. IT WAS MENTIONED THAT THE PRODUCT CAME IN CONTACT WITH PATIENT. IT WAS SUSPECTED THAT THE BREAK WAS OCCURRED BEFOREHAND. THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192515 ↗
• MalfunctionOct 19, 2020Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT SET SCREW DRIVER WAS OLD AND THE TIP WAS STRIPPED. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED. PRODUCT IS BEING RETURNED. UPDATE: PROCEDURE USED WAS LUMBAR FUSION. PATIENT CAME IN CONTACT WITH THE HARDWARE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10695537 ↗
• MalfunctionOct 13, 2020Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SET-SCREW USING DRIVERS FOR AN OLIF, FLIPPED POSTERIOR FOR PERC SCREWS. IT WAS REPORTED THAT THE SET SCREW DRIVERS WERE ALL STRIPPED AND WERE NOT ALLOWING FOR SET SCREW TO BREAK OFF. THEY HAD SEVERAL PANS STERILE THAT ALLOWED THEM TO FINISH THE CASE VIA THE BACK UP PANS. ALL 4 INSTRUMENTS WERE STRIPPED AND UNABLE TO BREAK OFF THE SET SCREWS. THE PATIENT IS DOING FINE, THEY HAD SEVERAL BACK UP PANS ALLOWING THEM TO FINISH THE CASE. THE PATIENT WAS IN CONTACT WITH THE INSTRUMENTS INTRA PROCEDURE, AND THERE WAS A 25 MIN. ADDITION TO THE PROCEDURE BECAUSE THEY HAD TO GO DOWN TO SPD FOR THEIR BACK UP PANS SEVERAL TIMES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. ALL DRIVERS WERE REPLACED BY MEDTRONIC PRODUCTS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10668659 ↗