Divergence® Anterior Cervical Fusion System G6626526Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169337497), received between Jan 2, 2017 and Sep 24, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fracture

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy. It was reported that during spinal surgery involving placement of an interbody implant and screws, the interbody implant was tamped to achieve appropriate positioning before placement of the left-sided screw. During attempted placement of the left-sided screw, the locking mechanism appeared irregular. The surgeon removed the screw and interbody implant, and the interbody implant was observed to be fractured near the center locking mechanism. The interbody implant was replaced with one replacement product. No patient complications have been reported as a result of this event. Additional information was received that there was no issue to the screw in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880732 ↗
• MalfunctionMar 26, 2026Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT A ZERO-PROFILE INTERBODY FUSION DEVICE FRACTURED. THE SCREW HOLE OFTHE FUSION DEVICE WAS DAMAGED, WHICH ALLOWED THE SCREW TO ADVANCE INTO THE VERTEBRAL BODY AND PREVENTED SUCCESSFUL FIXATION. AS A RESULT, THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED DURING THE PROCEDURE. 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 24696977 ↗
• MalfunctionAug 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING POSTERIOR AND ANTERIOR ARTHRODESIS. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 22735871 ↗
• MalfunctionJun 10, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY USING SELF-STABILIZING CERVICAL FUSION FIXATION SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS FRACTURED WHILE SCREWING. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AS THE EVENT OCCURRED DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174497 ↗
• MalfunctionApr 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE CAGE WAS IMPLANTED, IT WAS OBSERVED THAT THE FUSION CAGE WAS DAMAGED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. 2025-APR-07 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED CAGE WAS BROKEN. THERE IS NO MANUFACTURING ISSUE IDENTIFIED AND NO PATIENT COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872374 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C3-7 ACDF SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL STENOSIS. IT WAS REPORTED THAT WHEN HCP PLACED THE IMPLANT AND WENT TO FINAL TIGHTEN THE SET SCREW, IT WAS NOT FUNCTIONING PROPERLY. THE LOCKING MECHANISM WAS ABLE TO BE SPUN IN 360 DEGREES, RATHER THAN THE PROPER 90 DEGREE TURN. 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 21583575 ↗
• MalfunctionMar 11, 2025Mechanical Problem; Mechanical Problem

  ON (B)(6) 2023 MPXR 1046453 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A SPINAL INTERVERTEBRAL ACDF PROCEDURE AT C3/4 IN A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY/ CERVICAL DISC HERNIATION. IT WAS REPORTED THAT UNDER THE INTRAOPERATIVE IMAGE, A CAGE WAS PLACED USING A GUIDED INSERTER AFTER THE TRIAL. A SCREW PILOT HOLE WAS CREATED UNTIL THE SCREW WAS INSERTED. FINALLY, WHEN AN ATTEMPT WAS MADE TO TIGHTEN THE GOLDEN LOCKING CAP WITH THE SCREWDRIVER, WHEN IT WAS ROTATED TO 90 DEGREES, IT DID NOT STOP AND CONTINUED ROTATING. THE PHYSICIAN SELECTED WHETHER TO REINSERT A NEW CAGE OR TO STOP IT AT A 90 DEGREE ANGLE, AND IT WAS STOPPED WHEN IT WAS TURNED 90 DEGREES. 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 21571072 ↗
• MalfunctionMar 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN. CAGE WAS NEVER IMPLANTED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543346 ↗
• MalfunctionNov 10, 2024Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE HAVING CERVICAL ARTHRODESIS THERAPY FOR DEGENERATIVE DISC DISEASE (DDD). IT WAS REPORTED THAT THE STRUCTURE OF THE CAGE WAS DAMAGED WHEN INSERTED AND IMPACTED ON THE PATIENT, WITH A LATERAL CRACK. VISUALLY, CAGE APPEARED TO HAVE A PHYSICAL CHANGE IN APPEARANCE. ITS DIMENSIONAL COMPARED TO OTHER PREVIOUSLY USED CAGES. THERE WAS NO IMPROPER OR IRREGULAR USE OF THE MATERIAL AND THE SAME FOUND IN THE PATIENT. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT AND NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20648603 ↗
• InjuryOct 31, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT C5/6 ANT ERIOR CERVICAL DISCECTOMY AND FUSION FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT THE CAUDAL SCREW WAS CUT OUT AFTER SURGERY. ADDITIONAL SURGERY PLANNED TO REMOVE THE SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAGE HAS MOVED FROM THE RIGHT PLACE TO WRONG PLACE. REVISION SURGERY WAS PERFORMED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576303 ↗
• MalfunctionOct 22, 2024Crack; Crack

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE HCP PLACED THE IMPLANT IN POSITION USINGTHE FREEHAND INSERTER AND PUT THE SCREWS. WHEN THEY VIEWED VIA THE MICROSCOPE BEFORE ENGAGING THE LOCKING MECHANISM, THEY SAW A CRACK IN THE ANTERIOR PORTION OF THE IMPLANT NEAR THE LOCKING MECHANISM. ON SEEING THE CRACK ON THE IMPLANT, THEY REMOVED THE SCREWS AND REPLACED IT WITH A NEW DIVERGENCE STAND-ALONE CAGE AND FINISHED THE PROCEDURE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. (B)(6) 2024, UPDATE RECEIVED THE PROCEDURE WAS AN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) WHEN THE EVENT OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504132 ↗
• MalfunctionJun 6, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHODESIS FOR AN CERVICAL HERNIA. IT WAS REPORTED THAT THE CAGES HAD THEIR STRUCTURE DAMAGED WHEN THEY WERE INSERTED AND IMPACTED ON THE PATIENT. TWO OF THEM STILL ARE IN THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475075 ↗
• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS BROKE DURING THE HAMMERING. 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 19456748 ↗
• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS BROKE DURING THE HAMMERING. 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 19456740 ↗
• MalfunctionMay 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHRODESIS. IT WAS REPORTED THAT DURING INSERTION OF THE SCREW, THE CAGE BROKE. 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 19349674 ↗
• MalfunctionMay 13, 2024Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR CERVICAL INTERVERTEBRAL DISC HERNIATION. PROCEDURE OR TECHNIQUE USED WAS ACDF. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A SUSPECTED MANUFACTURING ISSUE WHEN THE PRODUCT WAS OPENED FROM THE BOX FOR THE FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296392 ↗
• MalfunctionMay 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR CERVICAL SPONDYLOTIC MYELOPATHY. PROCEDURE OR THERAPY PERFORMED WAS ACDF (ANTERIOR CERVICAL ACDF). IT WAS REPORTED THAT THE IMPLANT BROKE DURING THE IMPLANTATION PROCESS AND WAS REMOVED. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296372 ↗
• MalfunctionMay 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHODESIS DUE TO CERVICAL HERNIA. IT WAS REPORTED THAT WHEN INSERTING THE SCREW, THE CAGE BROKE, DEMONSTRATING FRAGILITY IN ITS STRUCTURE WHEN INSERTED INTO THE BONE. 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 19284876 ↗
• MalfunctionAug 3, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) THERAPY FOR CERVICAL SPONDYLOTIC RADICULOPATHY. IT WAS REPORTED THAT AFTER PLACING THE C5/6 CAGE, THE CAGE BROKE WHEN IT WAS TAPPED WITH A HAMMER DURING THE INSERTION OF THE C4/5 CAGE. SO THE CAGE WAS EXPLANTED AND NEW THE CAGE WAS PLACED INSTEAD. LEVELS IMPLANTED WERE C4/5, 5/6. THERE WAS A DELAY IN THE PROCEDURE. NO PATIENT SYMPTOMS WERE REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINS IN THIS PROCEDURE. THERE WAS NO REVISION SURGERY/ HOSPITALIZATION OCCURRED/ PLANNED AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449665 ↗
• MalfunctionFeb 23, 2023Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C6-7 ACDF FOR AN INDICATION OF ANTERIOR CERVICAL DISCECTOMY. IT WAS REPORTED THAT THE IMPLANT CRACKED DURING INSERTION WHEN THE DOCTOR IMPACTED THE INSERTER. 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 16425448 ↗
• MalfunctionNov 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE REGARDING CAGES USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE SURGERY BEGAN, THE DOCTOR REMOVED THE ENTIRE DISC AND PREPARED THE SPACE. HE USED THE GAUGE TO VERIFY THE HEIGHT OF THE DIVERGENCE BOX, AND A BOX WITH A HEIGHT OF 6MM WAS PLACED ON THE TABLE SINCE IT WAS THE MEASURE CHOSEN WITH THE DIVERGENCE GAUGE HEIGHT. IT WAS PLACED IN THE FREEHAND INSERTER AND FILLED WITH GRAFT, THE DOCTOR THEN PLACED IT IN THE SPACE AND RELEASED IT FROM THE INSERTER. HE THEN IMPACTED A LITTLE TO FINISH LOCATING IT, USING THE IMPACTOR AND THE HAMMER, THE CAGE FRACTURED WHERE THE LOCKING SCREW IS LOCATED. THE SURGEON REMOVED THE BOX AND THEN DECIDED TO REPLACE IT BY A 5MM HIGH DIVERGENCE CAGE. WHEN THE 5MM HIGH DIVERGENCE BOX WAS PASSED TO THE TABLE, IN THE SAME WAY IT WAS PLACED IN THE FREEHAND INSERTER AND FILLED WITH GRAFT. ONCE AGAIN, THE DOCTOR PLACED THE BOX, IT ENTERED THE SPACE MUCH MORE SMOOTHLY THAN THE PREVIOUS ONE SINCE IT WAS A LOWER HEIGHT, BUT IN THE SAME WAY WHEN IMPACTING IT A LITTLE TO FINISH ACCOMMODATING IT, THE CAGE FRACTURED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15768507 ↗
• MalfunctionOct 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN SPINAL THERAPY TO REINSERT INTO NEW CAGE. IT WAS REPORTED THAT THE CAGE WAS BROKEN AFTER SCREW INSERTION WHEN GUIDE WAS REMOVED. THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION WITH THE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15688648 ↗
• MalfunctionAug 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C5-6 ACDF FOR AN INDICATION OF C5-6 DISC HERNIATION. IT WAS REPORTED THAT THE DIVERGENCE CAGE 6MM WAS LOADED ON FREEHAND INSERTER AND WHILE IMPLANTING BETWEEN C5-6 DISC SPACE WITH SLIGHT TAPPING , THE CAGE BROKE. THE BROKEN CAGE WAS REMOVED AND WAS REPLACED BY THE NEW 6MM CAGE. 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 15280774 ↗
• MalfunctionApr 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN ANTERIOR CERVICAL SPINE C3/4, C4/5 CERVICAL DISCECTOMY, DECOMPRESSION AND FUSION (ACDF SURGERY) PROCEDURE IN A PATIENT DIAGNOSED WITH POSTERIOR LONGITUDINAL LIGAMENT OSSIFICATION (C4-6), CERVICAL SPONDYLOSIS, SPINAL CORD INJURY, DIABETES AND HYPERTENSION. IT WAS REPORTED THAT THE FUSION DEVICE WAS BROKEN. PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY / COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14019745 ↗
• MalfunctionNov 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT, CAGE WAS BROKEN IN PROCEDURE AND SO, THE BROKEN CAGE WAS REPLACED AND IMPLANTED A NEW CAGE. THE BROKEN CAGE CAME IN CONTACT WITH THE PATIENT BUT, THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WAS A DELAY OF ABOUT 5-10 MINUTES OCCURRED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12744879 ↗