N/A 2982001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885074549736), received between Aug 27, 2018 and Sep 16, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785794 ↗
• MalfunctionSep 9, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683773 ↗
• MalfunctionSep 8, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a product having Direct Lateral Interbody Fusion (DLIF) spinal therapy. It was reported that the device holder end was broken. There was no patient involvement reported and no further complications reported regarding the event. Additional information was received via manufacturer representative that the reported product was already used before.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50662080 ↗
• MalfunctionJun 9, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TRAYS INVOLVED IN THIS RETURN HAVE BEEN AGING FOR QUITE A LONG TIME. THE BENT TAP WAS FOUND IN ONE OF OUR TRAYS AND CLEARLY WAS DAMAGED AT SOME POINT, BUT NO ONE HAD NOTICED UNTIL TODAY. THE BROKEN OLIF INSERTER WAS ALSO FOUND IN A TRAY BROKEN AND NO ONE SEEMS TO KNOW WHAT HAPPENED TO IT OR WHEN IT BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE TAP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441916 ↗
• MalfunctionApr 1, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT HOLD PART IS SEPARATED. TOP OF THE INSERTER HAD BEEN BROKEN AND CANNOT HOLD THE IMPLANT IN PLACE. 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 24756817 ↗
• MalfunctionFeb 8, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN DIRECT LATERAL INTERBODY FUSION. IT WAS REPORTED THAT THE HOLDING PART OF THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288621 ↗
• MalfunctionDec 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DLIF PROCEDURE. IT WAS REPORTED THAT THE HOLD PART OF THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786075 ↗
• MalfunctionNov 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSERTER WAS NOT DELIVERED BROKEN. IT HAVE BEEN USED IN PREVIOUS SURGERIES SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601338 ↗
• MalfunctionJun 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR ARTHRODE SIS SPINAL THERAPY. IT WAS REPORTED THAT THE THREADED INSERTER HAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22262195 ↗
• MalfunctionDec 12, 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 INSERTER TIP HAS BROKEN. THE EVENT OCCURED ON THE BACK TABLE WHEN LOADING THE IMPLANT. 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 20910201 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR OLIF THERAPY. IT WAS REPORTED THAT THE FORK OF THE INSERTER WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. HERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751241 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR OLIF THERAPY. IT WAS REPORTED THAT THE FORK OF THE INSERTER WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. HERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751237 ↗
• MalfunctionJun 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR LAT ERAL SPINAL FUSION OF LUMBAR 3-4, LUMBAR 4-5. IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A DIRECT LATERAL SPINAL FUSION OF LUMBAR 3-4, LUMBAR 4-5 ON AN ELDERLY FEMALE. AFTER IMPLANTATION OF SPINAL INTERBODY SPACER IT WAS NOTED THAT A PIECE OF THE CLYDESDALE I NSERTER WAS BROKEN OFF. THE ONLY OTHER EQUIPMENT THAT WAS BEING USED AT THE TIME WAS A MALLET. THOROUGH EXAMINATION OF THE WOUND, VISUALLY AND VIA FLUOROSCOPY, THE SMALL BROKEN PIECE APPEARED TO NOT BE STILL IN THE PATIENT. OPERATING ROOM EXAMINATION WAS PERFORMED AND THE BROKEN PIECE WAS FOUND IN THE SUCTION CANISTER. ALL BROKEN PIECES WERE SEQUESTERED AND TAKEN OFF OF THE OR BACK TABLE. INSTRUMENT WAS THEN DECONTAMINATED AND SENT WITH THE MEDTRONIC REP TO BE SENT BACK TO THE MANUFACTURER AND A REPORT GENERATED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14559394 ↗
• MalfunctionApr 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPONDY. PROCEDURE OR TECHNIQUE USED WAS OLIF. LEVELS IMPLANTED L3-5. IT WAS REPORTED THAT DURING INSERTION OF THE IMPLANT, ONE OF THE TWO PRONGS OF THE INSERTER BROKE OFF. THE SURGEON COULD SEE IT ON X-RAY, REMOVED THE BROKEN PIECE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14199594 ↗
• MalfunctionFeb 10, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA ¿ OP FOR A PATIENT WITH A DIAGNOSIS OF A SPINAL STENOSIS. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN. IT WAS MENTIONED AS INSERTER BROKEN MID INSERTION CAUSING CAGE TO SPIN AROUND IN THE DISC SPACE. THIS WAS CAUGHT WITH X-RAY. IT WAS MENTIONED THAT INSERTION/EXTRACTION AND REPEATED RE-INSERTION USING EXTRACTION TOOL AS IT WAS THE ONLY VIABLE OPTION THAT COULD HOLD THE CAGE. REPEATED INSERTION AND EXTRACTION CAUSED EXTENDED TIME THROUGH OLIF RETRACTORS AND PROCEDURAL TIME. THERE WAS A DELAY OF 45 MINUTES OCCURRED AS A RESULT OF THIS EVENT. THE PROCEDURE INVOLVED DURING THIS EVENT WAS MENTIONED AS OLIF AND THE LEVELS IMPLANTED WERE MENTIONED AS L1-L3. THERE WERE NO SYMPTOMS TO PATIENT REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306600 ↗
• MalfunctionSep 27, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH OLIF THERAPY. IT WAS REPORTED THAT, DURING THE PROCEDURE CAGE WENT IN AND WHILE PULLING OUT IT WAS NOTICED THAT THE INSERTER WAS BROKEN, THE BROKEN PIECE WAS ALSO RETRIEVED THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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

  MAUDE report 10591380 ↗
• MalfunctionJun 26, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE (DDD) L2-L4-L5 PROCEDURE PERFORMED: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L3-L4/ L4-L5 INTRA-OP, AFTER PERFORM OLIF AT L4-L5 LEVEL, THE TIP OF THE INSERTER BROKE INSIDE THE CAGE WHILE PERFORMING OLIF AT L3-L5 LEVEL. HOWEVER SURGEON MANAGED TO REMOVE IT WITH A FORCEP. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199029 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DIRECT LATERAL INTERBODY FUSION AT L4-L5 DUE TO STENOSIS AND SPONDYLOLISTHESIS. INTRA-OP, THE INSTRUMENT BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324796 ↗
• MalfunctionNov 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, THE DISTAL TIP OF THE INSERTER BROKE DURING CAGE INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN INSTRUMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8099748 ↗
• MalfunctionNov 15, 2018Break; Break

  PATIENT DEMOGRAPHICS: INITIALS-(B)(6), GENDER- FEMALE, DOB- (B)(6) PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: STENOSIS TYPE OF PROCEDURE OR TECHNIQUE USED: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVEL OPERATED: L3-L4 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, DURING INSERTION OF THE CAGE, THE DISTAL TIP OF THE INSERTER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT, NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8072947 ↗
• MalfunctionAug 27, 2018Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE INSERTER BROKE DURING THE IMPLANTATION. IMPLANT WAS ALMOST PLACED WHEN ONE 'FINGER' OF THE INSERT ER BROKE OFF. FINAL PLACEMENT WAS COMPLETED WITH THE HELP OF COMPACTOR. NO BROKEN FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817846 ↗