N/A 7480113Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00721902861468), received between Jul 4, 2019 and Apr 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION BACK SURGERY FOR SCREW EXTRACTION. IT WAS REPORTED THAT A DRIVER SHAFT SHEARED AND THE DRIVER BROKE DURING AN ATTEMPTED SCREW EXTRACTION INTRA-OPERATIVELY. A SECOND DRIVER WAS USED TO COMPLETE THE SCREW EXTRACTION. NO INSTRUMENT FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015663 ↗
• MalfunctionFeb 5, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING HANDLES AND DRIVER. IT WAS REPORTED THAT HANDLE DID NOT RATCHET AND TIP OF THE DRIVER IS 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 24267872 ↗
• MalfunctionJun 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 POSTERIOR INSTRUMENTATION. IT WAS REPORTED THAT THE DRIVER BROKE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294731 ↗
• MalfunctionJun 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER IS BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147645 ↗
• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINE ARTHRODESIS FOR SCOLIOSIS. IT WAS REPORTED THAT A PART OF THE SCREWDRIVER CAME OFF WHEN PLACING THE SCREW AND IT WAS UNSOLDERED WITHOUT ANY FORCE OR INCORRECT MANEUVER. WHEN TRYING TO REMOVE THE SCREW WITH SCREWDRIVER, THE SCREWDRIVER BROKE AND BROKEN PART WAS RETRIEVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501485 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE WRENCH HAS 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 21289631 ↗
• MalfunctionMay 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A MAS SCREWDRIVER USED IN L3-S1 F USION. IT WAS REPORTED THAT WHILE IMPLANTING OF THE SCREW, HEX PORTION OF SCREWDRIVER BROKE AND FOUND IN THE SCREW HEAD. BROKEN PIECE RETRIEVED FROM SCREW HEAD BUT WAS DISCARDED/LOST. THERE WAS NO FRAGMENTS OF THE INSTRUMENT REMAINING IN THE PATIENT. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED FOR THIS EVENT. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS SPONDYLOLISTHESIS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937568 ↗
• MalfunctionNov 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A DISTRIBUTOR REGARDING PATIENT UNDERGOING SPINE - DEGENERATIVE LEGACY. IT WAS REPORTED THAT WHEN TRYING TO SCREW THE SCREWDRIVER INTO THE MULTIAXIAL SCREW, THE SCREWDRIVER HAD A SMALL BREAK AT ITS TIP, CAUSING THE SCREW TO NOT STAY FIRM IN THIS INSTRUMENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795906 ↗
• MalfunctionSep 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED IN LUMBAR ARTHRODESIS THERAPY. IT WAS REPORTED THAT THE DEVICE BROKE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390036 ↗
• MalfunctionJun 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS OF PATIENT WAS LUMBAR DISC HERNIATION WITH RADICULOPATHY, LUMBAR SPINAL STENOSIS, LUMBAR OSTEOARTHROPATHY. IT WAS REPORTED THAT, THE PATIENT UNDERWENT LUMBAR INTERNAL FIXATION SURGERY IN OTHER HOSPITAL IN 2012, USING OTHER BRAND OF INTERNAL FIXATION PRODUCT AT THAT TIME. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022. INTERNAL FIXATION WAS PERFORMED WITH MEDTRONIC SPINE LEGACY 5.5 SYSTEM SCREWS DURING THE OPERATION. DURING THE OPERATION, THE TIP OF THE NAILING DEVICE WAS BROKEN, AND THE BROKEN PART OF THE NAILING DEVICE REMAINED IN THE INNER CORE OF THE SCREW, SO THAT THE SCREW COULD NOT BE FIXED WITH THE ROD. IMMEDIATELY, THE SCREW WAS REMOVED, AND NEW MEDTRONIC SCREW WAS REPLACED FOR FIXATION. THE OPERATION WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES. THE PROCEDURE OR TECHNIQUE PERFORMED WAS REMOVAL OF LUMBAR INTERNAL FIXATION DEVICE, LUMBAR LAMINECTOMY AND DECOMPRESSION, NUCLEUS PULPOSUS EXPLORATION, INTERNAL FIXATION VIA PEDICLE SYSTEM, INTERTRANSVERSE BONE GRAFT FUSION. THERE WAS NO PATIENT SYM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602263 ↗
• MalfunctionMay 3, 2022Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM DISTRIBUTOR, HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PROCEDURE OR TECHNIQUE PERFORMED WAS VERTEBRAL SPINAL TREATMENT. IT WAS REPORTED THAT, DURING THE SURGICAL PROCEDURE WHEN PICKING UP THE SCREW PLACEMENT KEY, THE SCREW FITTING PART WAS LOOSE, MAKING ITS USE IMPOSSIBLE. THE KEY WHICH HAS LOOSENESS IS THE COMPONENT OF REPORTED DRIVER THAT IS HELD BY A PIN. THE KEY WAS NOT USED IN THE PROCEDURE BECAUSE IT WAS BROKEN. WHEN THE DOCTOR TOOK THE KEY, IT WAS NOTICED THAT THE TIP OF IT WAS LOOSE AND THAT SOMETHING HAD BROKEN. THEREFORE SURGEON CANNOT USE THIS KEY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14267306 ↗
• MalfunctionFeb 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT THE SCREWDRIVER OF THE SUPPORTING INSTRUMENT DURING THE OPERATION WAS BROKEN DURING USE AND COULD NOT BE TAKEN OUT BUT REMAINED IN THE BODY. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBER OF THE REPORTED DEVICE IS PR15M005. NO OTHER SURGICAL OPERATIONS HAD BEEN PERFORMED, AND THE SUPPORTING INSTRUMENT FRAGMENTS HAD BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576840 ↗
• MalfunctionDec 9, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. LEVELS IMPLANTED D7-L5. PROCEDURE OR TECHNIQUE USED WAS DEFORMITY CORRECTION. IT WAS REPORTED THAT THE SCREW <(>&<)> DRIVER WERE DAMAGE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE EVENT OCCURRED WHILE INSERTING THE SCREW. ONLY THE DRIVER WAS BROKEN AND WAS PART OF THE DRIVER WAS WITHIN THE SCREW AND DUE TO WHICH THE SCREW ALSO WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965928 ↗
• MalfunctionFeb 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE DRIVER WAS BROKEN DURING INTRA-OP. THE PROCEDURE WAS CONTINUED AFTER REPLACING THE BROKEN DRIVER. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-FEB-09: THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-FEB-20: THE CUSTOMER REFUSED TO RETURN THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363869 ↗
• MalfunctionSep 16, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) AND DISTRIBUTOR VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER FOR A LUMBAR SPINE ARTHRODESIS. IT WAS REPORTED THAT THE DRIVER PURCHASED BY THE DISTRIBUTOR BROKE WHEN TIGHTENING THE SCREW DURING SURGERY (INTRA-OP). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CAME IN CONTACT WITH THE PRODUCT WHEN THE KEY BROKE WHILE TIGHTENING THE SCREW THAT WAS IMPLANTED IN THE PATIENT. ONLY THE KEY BROKE AND THERE WAS NO DAMAGE TO THE SCREW IMPLANTED IN THE PATIENT. THE PRE- OP DIAGNOSIS WAS LUMBAR HERNIA AND THE LEVELS IMPLANTED WERE L4-L5 AND L5-S1. THERE WAS NO ADDITIONAL SURGERY/ NECESSITATED INTERVENTION/ IN- PATIENT OR EXTENSION OF PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

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

  MAUDE report 10539965 ↗
• MalfunctionAug 19, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED. THERE WAS A DELAY OF 10MINUTES REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

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

  MAUDE report 10424078 ↗
• MalfunctionJul 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACO LUMBAR ARTHRODESIS. INTRA-OP, KEY OF THE DRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762219 ↗