N/A 2980001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00721902996689), received between Aug 9, 2017 and Mar 2, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAP Y. IT WAS REPORTED THAT THE HANDLE IS LOOSE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED RE GARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PLI 20 INSTRUMENT WAS DROPPED ON THE FLOOR AND THE TIP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480824 ↗
• MalfunctionJan 20, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113721 ↗
• MalfunctionApr 14, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR AN IND ICATION OF SYNOVIAL CYST AND L5-S1 STENOSIS. IT WAS REPORTED THAT UPON INSERTION OF THE CAPSTONE CAGE, ONE OF THE TABS AT THE END OF THE INSERTER BROKE OFF. 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 16741311 ↗
• MalfunctionAug 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4-L5 SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE INSERTER BROKE DURING THE PROCEDURE. PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201703 ↗
• MalfunctionOct 5, 2020Product Quality Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) (LEVELS IMPLANTED L4-L5) DUE TO DEGENERATIVE DISC L4-L5 LEVEL. IT WAS REPORTED THAT AFTER CAPSTONE CAGE WAS INSERTED IN ROD INSERTER , SURGEON INSERTED IT IN THE L4-L5 LEVEL, AFTER HAMMERING , THE SCREW AT END GOT LOOSE AND DR TRIED TO TIGHTEN IT , BUT IT DIDN'T HAPPEN. BUT THE CAGE WAS INSERTED INSIDE THE DISC SPACE AT APPROPRIATE DESIRED PLACE. WHEN ROD INSERTER WAS REMOVED , IT HAD SPIRAL THREADING OF THE CAPSTONE PEEK MATERIAL ATTACHED TO IT. INSERTER HAD SMALLER THREADING PART THAN USUAL. IT CAUSED THE SCREW TO LOOSEN UP WHILE HAMMERING AND WHEN SURGEON TRIED TO TIGHTEN THE SCREW AGAIN, THERE WAS A CROSS THREADING AND PEEK MATERIAL SPIRAL THREADING WAS SEEN AT THE END OF THE INSERTER WHEN REMOVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PRODUCT REMAINS IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10625985 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, WHILE PLACING THE INTERBODY DEVICE AT L4-L5 DISC SPACE AND PERFORMING AN AGGRESSIVE ORTHOGONAL MANEUVER, THE SIDE TAB OF THE INSERTER BROKE OFF AND THE INSERTER RELEASED FROM THE INTERBODY DEVICE. THE CAGE WAS THEN EXTRACTED USING THE EXTRACTOR TOOL AND THE SURGEON DECIDED TO USE ANOTHER TYPE OF INTERBODY CAGE DUE TO THE ANGLE THAT THE DEVICE WOULD BE PLACED AT. THE METAL PIECE OF THE BROKEN DEVICE WAS RETRIEVED BY SUCTION PROCESS. NO FRAGMENT OF THE BROKEN DEVICE REMAINED INSIDE THE PATENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10161050 ↗
• InjuryJan 2, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L2-S1 FUSION DUE TO L2-L4 STENOSIS. THE SCREW AT S1 WAS REPLACED ON THE LEFT; AND THE BACKED-OUT CAGE AT L4-L5 WAS REPLACED. INTRA-OP, AS THE INSERTER WAS BEING USED TO REMOVE THE CAGE, IT BROKE. THE EXTRACTOR WAS NOT USED FOR THIS PURPOSE BECAUSE IT WAS NOT AVAILABLE AND WAS ON BACK-ORDER. WHEN THE SURGEON TWISTED THE INSERTER, A SMALL PIECE AT THE END OF THE INSERTER BROKE OFF. THERE WAS A DURAL TEAR ALREADY PRESENT; AND THE BROKEN PIECE FELL INTO THE DURA. THE SURGEON THEN PERFORMED A LAMINECTOMY, AND MADE AN INCISION TO RECOVER THE BROKEN PIECE OF THE INSERTER. NO FRAGMENT OF THE BROKEN INSERTER REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9541970 ↗
• MalfunctionJul 22, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: INTERBODY CAGE SHIFTED OUT OF PLACE LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT INTRA-OP, THE TAB ON INSERTER BROKE OFF WHILE THE SURGEON TRIED TO ENGAGE THREADED INSERTER IN THE CAGE. TAB BROKE OFF IN ONE PIECE AND WAS EASILY REMOVED FROM THE PATIENT WITH FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8810415 ↗
• MalfunctionJan 31, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION DUE TO DEGENERATIVE DISC DISEASE. INTRA-OP, THE IMPLANT WAS NOT ABLE TO LOAD STRAIGHT ONTO THE INSERTER. ALSO, THE IMPLANT COULD NOT BE LOADED SECURELY ONTO INSERTER, IT REMAINED LOOSE REGARDLESS OF TIGHTENING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292005 ↗
• MalfunctionMar 29, 2018Break; Break

  PRE-OP MEDICAL HISTORY: POSTERIOR LUMBAR DECOMPRESSION AND FIXATION. IT WAS REPORTED THAT DURING SURGERY, PART OF THE CAGE HOLDER SHAFT WAS BROKEN DURING INSERTION AND ALLOCATION OF THE CAGE DURING INTERBODY FUSION. THE DEVICE CAME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF CAGE HOLDER. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380613 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY AT L3-5 DUE TO SPINAL STENOSIS. INTRA-OP, ONE OF THE INSERTER PIN BROKE WHEN THE IMPLANT WAS FIXED ON THE INSTRUMENT. NO PATIENT COMPLICATIONS REPORTED AS A RESULT EVENT. NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062482 ↗
• MalfunctionAug 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A FUSION SURGERY. INTRA-OP, TIP OF THE THREADED INSERTER BROKE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783831 ↗
• MalfunctionAug 9, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT LEVELS L5-S1.INTRA-OP, INSERTER TIP BROKE OFF DURING IMPLANTATION. BROKEN TIP WAS RETRIEVED SUCCESSFULLY.THERE WERE NO FRAGMENTS OF INSTRUMENT REMAINING INSIDE THE PATIENT. NO PATIENT SYMPTOMS/COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776249 ↗