Medtronic Reusable Instruments 2990001Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00613994803061), received between Aug 9, 2017 and Jul 28, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 18, 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.

• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50049588 ↗
• MalfunctionApr 10, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-L5 REVISION AND REMOVAL OF EXISTING HARDWARE SOLERA 4.75 PEDICAL SCREWS AND ADAPTIX INTERBODY. SURGEON EXPOSED PATIENT REMOVING OLD SOLERA 4.75 SET SCREWS, RODS, AND PEDICLE SCREWS. SURGEON THEN EXPOSED TO THE EXISTING ADAPTIX INTERBODY AND TRIED TO ATTACH AND REMOVE WITH ORIGINAL ADAPTIX INSERTER. IT WAS REPORTED THAT SURGEON WAS REMOVING EXISTING ADAPTIX INTERBODY WITH PROPER INSERTER (2990001) HE THOUGHT IT WAS ATTACHED TO EXISTING INTERBODY IN PATIENT SO HE TWIST THE INSTRUMENT AND BROKE ONE OF THE TIPS OFF THAT ATTACHES AROUND THE IMPLANT. SURGEON DID MALLET THE INSERTER BEFORE TWISTING EVEN THOUGH HE WAS ADVISED NOT TO MALLET THE INSTRUMENT PER  TECHNIQUE. BROKEN TIP WAS REMOVED FROM PATIENT AND BROKEN INSERTER WAS REMOVED FROM SURGICAL FIELD. INTERBODY WAS REMOVED USING A UNIVERSAL  REMOVAL TOOL MAKING SURE ALL AND EVERYTHING WAS REMOVED FROM THE PATIENT. SURGEON TOOK A 3D IMAGE USING  O-ARM CHECKING NOTHING REMAINED IN THE PATIENT. SURGEON THEN PLACED NEW ADDITIONAL SOLERA 4.75 PEDICLE SCREWS, RODS, AND SETSCREWS. FINALLY SURGEON PERFORMED ANOTHER 3D IMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840632 ↗
• MalfunctionMar 24, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE REMOVING AN OLD IMPLANT, THE INSERTER TIP BROKE AND THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE PATIENT. 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 24680073 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY. IT WAS REPORTED THAT AFTER INSERTING THE CAGE AND REMOVING THE INSERTER, IT WAS NOTICED THAT THE TIP WAS DAMAGED. THE INSERTED CAGE WAS TEMPORARILY REMOVED, AND IMAGING REVEALED THE FRAGMENT INSIDE THE INTERVERTEBRAL DISC WHICH WAS REMOVED USING A HERNIA FORCEPS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT INSERTER WAS BROKEN AND SEPARATED STATE AT 6 MM FROM THE TIP OF THE DISTAL PART. WHEN THE INSERTER AND CAGE BETWEEN THE VERTEBRAE WERE INSERTED AND THE INSERTER WAS REMOVED, THE TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575097 ↗
• MalfunctionDec 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY SPINAL THERAPY FOR L4 DEGENERATIVE SPONDYLOLISTHESIS TO L4/5 LEVELS. IT WAS REPORTED THAT AN AA 24×10 MM CAGE WAS INSERTED AT L4/5. AFTER REMOVING THE INSERTER, A SLIGHT INWARD TILT OF THE CAGE WAS REQUESTED. THE INSERTER WAS REINTRODUCED INTO THE DISC SPACE, AND THE INNER SHAFT WAS ROTATED SEVERAL TIMES TO ADJUST. A ¿CLICK¿ WAS HEARD, AND UPON REMOVAL, ONE TINE OF THE BIFURCATED INSERTER TIP WAS MISSING. THE FRAGMENT WAS RETRIEVED FROM THE BODY USING A PUNCH AND FORCEPS IN APPROXIMATELY 2 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE SIGNS OF WEAR ON THE THREADS APPROXIMATELY 2.3 CM FROM THE HEAD FOR PLI 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919247 ↗
• MalfunctionAug 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/5 TLIF THERAPY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT ONE OF THE INSERTER TIP'S FORKS WAS BROKEN AND REMAINED IN THE DISC, SO IT WAS REMOVED WITH A SENSE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. 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 22882128 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A INSERTER USED FOR SPIN AL THERAPY. IT WAS REPORTED THAT ONE OF THE CLIPS THAT MATES WITH THE IMPLANT WAS MISSING FROM THE BASE. 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 22607315 ↗
• MalfunctionJan 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN INSERTER USED ON A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR L4/5 LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE DEFECT OCCURRED DURING AN UNATTENDED PROCEDURE. DURING TLIF OF L4/5, THE DISTRIBUTOR INFORMED THAT THE PART (CLAW) AT THE TIP OF THE DEFECTIVE PRODUCT WAS BROKEN DURING THE INSERTION OF THE IMPLANT THAT WAS HELD/GRASPED BY THE DEFECTIVE PRODUCT. THE ENTIRE BROKEN PART WAS REMOVED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE PROCEDURE. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF EVENT. 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 18482424 ↗
• MalfunctionFeb 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF AT L3/4 DUE TO DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO ROTATE THE PROXIMAL END OF THE IMPLANT MORE POSTERIOR WHEN THE INSERTER BROKE. THE INSTRUMENT WAS REPLACED AND THE SECOND INSTRUMENT WAS BROKEN AS THE IMPLANT WAS MALLETTED INTO ITS FINAL POSITION. 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 16384436 ↗
• MalfunctionFeb 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF AT L3/4 DUE TO DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO ROTATE THE PROXIMAL END OF THE IMPLANT MORE POSTERIOR WHEN THE INSERTER BROKE. THE INSTRUMENT WAS REPLACED AND THE SECOND INSTRUMENT WAS BROKEN AS THE IMPLANT WAS MALLETTED INTO ITS FINAL POSITION. 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 16384434 ↗
• MalfunctionFeb 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, WHILE INSERTING A CLYDESDALE CAGE AT L3/4 DURING AN OLIF THE INSERTER BROKE. THE SURGEON WAS ATTEMPTING TO ROTATE THE CAGE MORE ANTEROLATERAL WHEN THE INSTRUMENT BROKE. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT LEFT INSIDE PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED ADDITIONALLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384096 ↗
• MalfunctionSep 9, 2022Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, WHILE TRYING TO IMPLANT THE CAGE THE SURGEON HAD DIFFICULTY IN GETTING IT TO ADVANCE ACROSS THE DISC SPACE. WHILE THE SURGEON WAS TWISTING THE HANDLE, ONE OF THE TIPS BROKE OFF. THE BROKEN TIP WAS RETRIEVED. NO INJURIES OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS. THE PROCEDURE OR TECHNIQUE PERFORMED WAS DIRECT LATERAL INTERBODY FUSION. THE LEVELS IMPLANTED WERE L2/L3. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15389684 ↗
• MalfunctionMay 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT TRANSVER TEBRAL INTERBODY FUSION SPINAL PROCEDURE FOR LUMBAR VERTEBRAL FUSION. IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED, THE TIP WAS HANGING WHEN THIS PRODUCT WAS PLACED ON MAYO STAND. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WAS BROKEN. THERE IS NO ALLEGATION/ MALFUNCTION AGAINST THE SHAFT AND CAGE. THE REPORTED INSERTER CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14423211 ↗
• MalfunctionApr 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT, AA8 MM WAS USED FOR L2/L3PLIF. THE CLAW ON THE TIP OF THE INSERTER WAS BROKEN WHEN THE INSERTER WAS REMOVED AFTER PLACING THE CAGE. THE BROKEN CLAW WAS COLLECTED WITH LOCKING HEMOSTATIC FORCEPS. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT OF PRODUCT MALFUNCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT. NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165521 ↗
• MalfunctionApr 8, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PLIF THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS BROKEN WHEN THE CAGE WAS INSERTED. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14049730 ↗
• MalfunctionMar 8, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN INSERTER AND COMPRESSOR IN AN OLIF L4/5- REVISION PLF L4-S1 FOR DEGENERATIVE DISC DISEASE, ARTHRODESIS. IT WAS REPORTED THAT THE THE SURGEON WAS USING THE INSERTER CORRECTLY WHEN IT BROKE. THERE WAS NO FRAGMENT OF THE INSERTER REMAINING IN THE PATIENT'S BODY. THE SURGEON WAS USING THE COMPRESSOR CORRECTLY WHEN THE TIP BENT. REPLACEMENT INSTRUMENTS WERE OPENED THE AND CASE CONTINUED ON SUCCESSFULLY. THE REVISION WAS AN ADD-ON. THE SURGEON ADDED IMPLANTS TO THE LEVEL ABOVE THE PREVIOUS SURGERY DUE TO ADJACENT LEVEL DISEASE. THERE WERE NO ALLEGATIONS AGAINST ANY OF THE PREVIOUSLY IMPLANTED MDT PRODUCTS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692667 ↗
• MalfunctionNov 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS. PROCEDURE OR TECHNIQUE USED WAS L3-L5 TLIF. LEVELS IMPLANTED L3-4. IT WAS REPORTED THAT WHILE INSERTING A CAGE THE TIP OF THE INSERTER BROKE OFF INSIDE OF CAGE. THE FRAGMENT WAS RETRIEVED FROM INSIDE THE CAGE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO HARM WAS CAUSED BY THE INSTRUMENT BREAKING, NO PIECES WERE LEFT INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817902 ↗
• MalfunctionMar 19, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPINAL CANAL STENOSIS, UNDERGOING A POSTERIOR LUMBAR VERTEBRA FUSION PROCEDURE. IT WAS REPORTED THAT IT WAS A PATIENT WITH VERY HARDENED VERTEBRAL BODY END PLATE AND RELATIVELY LOW INTERVERTEBRAL HEIGHT. WHEN INSERTING THE PT CAGE INTO L4 / 5, THE END PLATE WAS HARDENED AND THE INTERVERTEBRAL SPACE WAS NARROW, SO IT WAS INSERTED WHILE HITTING THE INSERTER STRONGLY WITH A PLASTIC HAMMER. WHEN TALKING ABOUT THE INSERTER AS A CAGE, ONE OF THE TWO CLAWS OF THE INSERTER WAS MISSING. AFTER CHECKING WITH THE IMAGE, IT WAS CONFIRMED THAT THE BROKEN INSERTER TIP WAS IN THE INTERVERTEBRAL DISC SPACE. IT HAD MANAGED TO GET BROKEN PART OFF WITH HERNIA FORCEPS. THERE WAS A DELAY OF LESS THAN 60 MIN. INITIAL REPORTER INFORMATION AND PATIENT INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. LEVELS IMPLANTED: L4/5 WHEN THE REPORTED INSERTER WAS REMOVED AFTER THE CAGE WAS PLACED, THE CLAW AT THE TIP WAS BROKEN ON ONE SIDE. SINCE THE BROKEN CLAW WAS COLLECTED, IT DID NOT REMAIN IN THE PATIENT¿S BODY. THE CAGE USED WAS 8X22 AND IS BEIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11522374 ↗
• MalfunctionFeb 10, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL SURGERY. LEVELS IMPLANTED L2/3,3/4,4/5. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT AFTER INSERTING THE CAGE IN THE ORDER OF L2/ 3, L3/ 4, AND L4/ 5, IT WAS NOTED THAT THE TIP GRIP OF THE INSERTER WAS MISSING. WHEN EACH INTERVERTEBRAL SPACE WAS CHECKED BY INTRAOPERATIVE FLUOROSCOPY, A SMALL SHADOW WAS FOUND ON L3/ 4, AND IT WAS MANAGED TO BE REMOVED USING SUCTION. BREAK WAS REPORTED. NO DEVICE FRAGMENT LEFT IN PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306181 ↗
• MalfunctionJan 18, 2021Break; Break

  HOLD FOR R.G. 1.20INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF SPINAL STENOSIS IN NEED OF L3/5 TWO LEVEL LUMBAR FUSION USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER TIP BROKE DURING CAGE MANIPULATION AFTER INSERTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WAS NO DELAY REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11183855 ↗
• InjuryOct 6, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT (MEDICAL HISTORY-DIABETES) HAVING PLIF (POSTERIOR LUMBAR INTERBODY FUSION)(LEVELS IMPLANTED -L3/L5) DUE TO LUMBAR CANAL STENOSIS(LCS). IT WAS REPORTED THAT AFTER THE CAGE WAS INSERTED, THE TIP OF THE INSERTER BROKE DUE TO A SLIGHT TWIST TO ADJUST THE POSITION. THE TIP OF THE INSERTER REMAINED ON THE GRIP PART OF THE CAGE. ALTHOUGH THE CAGE WAS ATTEMPTED TO BE REMOVED, IT WAS DIFFICULT, SO THE CAGE WAS LEFT AS IT WAS. THERE WERE NO PATIENT SYMPTOMS AS A RESULT OF THE EVENT. THE PRODUCT RETURN WAS REQUESTED. THERE WAS A PROCEDURAL DELAY OF LESS THAN 60 MINS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10633989 ↗
• MalfunctionAug 19, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED IN A INTERVERTEB RAL DISCS INTERBODY FUSION SURGERY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT DURING PROCEDURE WHILE HAMMERING THE CAGE A CRACK SOUND WAS HEARD, SO THE INSERTER WAS REMOVED, CAGE AND THE INSTRUMENT WERE CHECKED. THE INSERTER BROKE WHILE SETTING THE THIRD CAGE. THERE WAS A DELAY IN OVERALL PROCEDURE TIME OF LESS THAN 60 MIN. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED. PLIF WAS PERFORMED AT 2 INTERVERTEBRAL SPACES OF L4/S. THE FIRST CAGE WAS INSERTED TO L4/5 WITH THE REPORTED INSERTER, WHEN THE POSITION WAS CHECKED WITH IMAGE, THE DOCTOR HEAR AN ABNORMAL SOUND WHILE MOVING THE INSERTER TO ADJUST THE POSITION. WHEN THE INSERTER WAS CHECKED OUTSIDE THE OPERATING FIELD, A CRACK WAS NOTED AT THE TIP CLAW. THE SECOND CAGE WAS CONTINUED TO BE INSERTED. WHEN THE THIRD CAGE WAS SET, THE CLAW PART BROKE AND DETACHED. AS THERE WAS NO ALTERNATIVE ONE, THE INSERTER WAS USED AS IT WAS, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. IT SEEMED THAT TH

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

  MAUDE report 10424015 ↗
• MalfunctionJul 22, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT FOR POSTERIOR LUMBAR INTERBODY FUSION (PLIF). IT WAS REPORTED THAT DURING INTRA-OPERATING SURGERY, THE TIP OF IMPLANT HOLDER BROKE DURING CAGE INSERTION,THE PRODUCT DID NOT CAME IN CONTACT WITH THE PATIENT AS THERE WAS A SOUND DURING INSERTING AND IT SEEMED THAT THE PRODUCT BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AND NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10306956 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR CANAL STENOSIS. INTRA-OPERATIVELY, THE TIP OF THE INSERTER WAS FOUND TO BE BROKEN OFF WHEN THE INSERTER WAS REMOVED AFTER PLACING THE CAGE AT L5/S. THE BROKEN TIP WAS FOUND IN THE OPERATIVE FIELD WHEN THE REPORTED INSERTER WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT. THE PATIENT ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9278061 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH KYPHOSIS; AND UNDERWENT L2-L3 POSTERIOR LUMBAR INTERBODY FUSION, L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION AND L4 PEDICLE SUBTRACTION OSTEOTOMY. INTRA-OP, AFTER HAMMERING THE FIRST CAGE AT L4-L5, IT WAS NOTICED THAT THE CLAW PART OF THE INSERTER REMAINED IN THE CAGE. THIS WAS FOUND IN THE IMAGE AFTER THE PLACEMENT OF THE CAGE. THE PHYSICIAN TRIED TO REMOVE THE BROKEN PART BY SUCTION OF BLOOD. WHEN PERFORMING SUCTION, THE BROKEN PART COULD NOT BE FOUND IN THE PATIENT¿S BODY, AND THE BROKEN PART WAS FOUND MISSING. IT COULD NOT BE DETERMINED IF THE BROKEN FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT OR NOT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703552 ↗