ELEVATE™ Spinal System 7770723Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169430433), received between Feb 10, 2017 and Sep 28, 2026 — classified as 4 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Information was received from multiple sources (Healthcare Provider, Distributor) regarding a patient having Minimally Invasive Tran sforaminal Lumbar Interbody Fusion for L3-L4 herniated intervertebral disc (HIVD). It was reported that after the cage was implanted and expanded, an X-ray was taken to confirm its position. The imaging revealed that the PEEK component had separated and broken. The surgeon did the same procedure with the new one, the cage separated and broken too. A new cage of the bigger size was selected and implanted. This replacement expanded successfully without further complications, and the surgery was completed as planned. 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 50912231 ↗
• MalfunctionSep 28, 2026Break

  Information was received from multiple sources (Healthcare Provider, Distributor) regarding a patient having Minimally Invasive Tran sforaminal Lumbar Interbody Fusion for L3-L4 herniated intervertebral disc (HIVD). It was reported that after the cage was implanted and expanded, an X-ray was taken to confirm its position. The imaging revealed that the PEEK component had separated and broken. The surgeon did the same procedure with the new one, the cage separated and broken too. A new cage of the bigger size was selected and implanted. This replacement expanded successfully without further complications, and the surgery was completed as planned. 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 50912163 ↗
• MalfunctionOct 21, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE VIA A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) FOR AN INDICATION OF L5-S1 HERNIATED INTERVERTEBRAL DISC. IT WAS REPORTED THAT AFTER SIZING WITH TRIAL INSTRUMENTS, THE SELECTED IMPLANT WAS INSERTED, AND A LOOSE TACTILE SENSATION WAS NOTED PRIOR TO EXPANSION. THE IMPLANT WAS REMOVED FOR INSPECTION AND WAS FOUND TO HAVE A FRACTURED SURFACE ON THE PEEK MATERIAL. THE IMPLANT WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS SAFELY AND SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345631 ↗
• MalfunctionSep 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT COULD NOT BE EXPANDED. 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 23085045 ↗
• MalfunctionMar 5, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FORM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT CAGE WOULD NOT COLLAPSE. NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL UPDATE RECEIVED TLIF PROCEDURE USED AND PRODUCT NOT CAME IN CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527726 ↗
• MalfunctionJan 9, 2025Break; Break

  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 THE PRODUCT BROKE WHILE IMPACTING INTO THE DISC SPACE. 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 21110116 ↗
• MalfunctionJan 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT BEFORE INSERTING THE CORRESPONDING CAGE, THE DEVICE WAS FOUND TO BE BROKEN DURING THE OPERATION CHECK OF THE EV. THE DETAILS OF THE BREAKAGE ARE UNKNOWN. THE PATIENT WAS ON THE OPERATION TABLE WHEN THE PRODUCT PROBLEM WAS IDENTIFIED. 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 21065169 ↗
• MalfunctionAug 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MIS TLIF THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE BROKEN. 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 20021462 ↗
• MalfunctionAug 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MIS TLIF THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE BROKEN. 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 20018965 ↗
• MalfunctionJul 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5-S1 TLIF FOR AN INDICATION OF HIVD. IT WAS REPORTED THAT WHEN SURGEON INSERTED THE IMPLANT COMPLETELYAND TRY TO EXPAND THE IMPLANT, IT WAS FOUND THAT THE CAGE WAS BROKEN AND THE SURGEON REMOVE IT COMPLETELY AND REPLACED WITH THE NEW ONE TO COMPLETE THE SURGERY. 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 19641795 ↗
• MalfunctionJan 15, 2024Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT FOR THE FIRST CAGE, AFTER CONNECTING THE TOOLS TO THE IMPLANT, THE PHYSICIAN NOTICED FRAGMENTS APPEARING WHILE ATTEMPTING TO INSERT THE IMPLANT. UPON REMOVAL, IT WAS DISCOVERED THAT THE IMPLANT HAD BEEN DAMAGED. AFTER A PREVIOUS UNSUCCESSFUL ATTEMPT, THE PHYSICIAN OPTED FOR ANOTHER IMPLANT. FOLLOWING THE SAME PROCEDURE AS BEFORE, WHEN ATTEMPTING TO INSERT IT, THE ENTIRE IMPLANT SHATTERED. 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 18515252 ↗
• MalfunctionJul 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE ELEVATE CAGE WAS CLOSED BEFORE IMPLANTATION. WHEN THE SURGEON WENT TO INSERT IT EXPANDED AND 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 17422814 ↗
• MalfunctionJun 20, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A PLIF FOR AN LCS AT L4/5. IT WAS REPORTED THAT THE CAGE BACKED OUT. IT WAS UNKNOWN IF THERE WERE ANY 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 17160590 ↗
• MalfunctionMar 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A MINIMAL ACCESS SPINE TECHNIQUE TO DO AN L5-S1 FUSION AND TLIF FOR SPONDYLOLISTHESIS WITH CENTRAL CANAL STENOSIS WHICH INCLUDED RIGHT SIDE RADICULOPATHY. IT WAS REPORTED THAT THE PRODUCT WAS INSERTED AND AN INTEROPERATIVE X-RAY WAS THEN TAKEN. IT WAS CLEAR ON THE X-RAY THAT THE CAGE WAS BROKEN. THE SURGEON ONLY MANAGED TO REMOVE THE PEEK ASPECT OF THE CAGE AND THE TITANIUM PART WAS LEFT BEHIND. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF AROUND 15 MINUTES DUE TO TIME TAKEN TO RETRIEVE PART OF THE CAGE INTEROPERATIVELY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16520021 ↗
• MalfunctionDec 8, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL, DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT LEVEL L4/5. IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED, THE CAGE WAS BROKEN. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. 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 15937774 ↗
• MalfunctionOct 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN EXPANDABLE CAGE USED IN L5/S1 PLIF THERAPY FOR DEGENERATIVE DISC DISEASE WITH SPONDYLITIS. IT WAS REPORTED THAT THE IMPLANT WAS LOADED ONTO THE INSERTER AS DESCRIBED IN THE SURGICAL TECHNIQUE. THE IMPLANT WAS CONFIRMED TO BE FULLY COLLAPSED PRIOR TO INSERTION. A SMALL MALLET WAS USED TO INSERT THE IMPLANT INTO THE DISC SPACE. DURING THE INSERTION PROCESS, THE PEEK COMPONENT OF THE SPACER FRACTURED AND BROKE APART. THE CAGE WAS IMMEDIATELY EXPLANTED AND ALL COMPONENTS OF THE CAGE WERE SAFELY REMOVED, WITH NO HARM TO THE PATIENT. L5/S1 WAS THE DISC SPACE INSTRUMENTED. THE DISC SPACE HAD COLLAPSED ENTIRELY AND WAS EXTREMELY TIGHT. DILATION VIA SPREADERS AND SHAVERS WAS COMPLETED UP TO 9MM. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672280 ↗
• MalfunctionOct 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR SPINAL STENOSIS DUE TO THE 4TH LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT, EVENT OCCURRED WHEN THE CAGE WAS INSERTED BETWEEN VERTEBRAL BODIES DURING THE PROCEDURE. THE PHYSICIAN COMPLAINED THAT THE LID OF THE CAGE WAS LOOSE WHEN IT WAS HIT WITH A PLASTIC HAMMER, AND IT WAS REMOVED OUTSIDE THE OPERATIVE FIELD, AND IT WAS CONFIRMED THAT THE CAGE WAS BROKEN. THE PROCEDURE OR TECHNIQUE PERFORMED WAS 4TH AND 5TH POSTERIOR LUMBAR INTERBODY FUSION. THE PART OF BONE OF THE PATIENT WAS FILLED INSIDE THE CAGE, SO IT WAS DISPOSED OF IN THE HOSPITAL. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT. THERE WERE NO FRAGMENTS OF BROKEN CAGE REMAINS IN PATIENT BODY. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549549 ↗
• MalfunctionSep 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR BACK / LEG PAIN. IT WAS REPORTED THAT, CAGE WAS BROKEN DURING IMPLANTATION. THE REPORTED PRODUCT CAME IN CONTACT WITH PATIENT BODY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO TIME DELAY IN PROCEDURE REPORTED AS A RESULT. NO FRAGMENTS OF BROKEN CAGE REMAINS IN PATIENT BODY. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500337 ↗
• MalfunctionAug 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR SPINAL STENOSIS. LEVEL AT WHICH THE IMPLANT WAS PERFORMED: L5/S1 IT WAS REPORTED THAT THE CAGE WAS HELD ONTO THE INSERTER IN A NORMAL WAY AS STATED IN THE PROCEDURE MANUAL. AFTER INSERTION INTO THE INTERVERTEBRAL SPACE, THE JACK-UP DRIVER WAS INSERTED AND ROTATED BUT IMMEDIATELY IT MADE AN ABNORMAL SOUND (LIKE SNAP SOUND), AND THE DRIVER WAS IDLING NO MATTER HOW MANY TIMES IT IS ROTATED. IT WAS CHECKED BY ROTATING IT UNDER FLUOROSCOPY AND IT WAS CONFIRMED THAT IT WAS NOT JACKED UP. IT WAS DETERMINED THAT A DEFECT HAD OCCURRED, AND THEN IT WAS REMOVED. WHEN IT WAS CHECKED OUTSIDE THE OPERATION FIELD, THE RING OF THE SCREW THAT JACKS UP THE CAGE WAS BROKEN. THE PRODUCT WAS CONTACT WITH THE PATIENT. 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 15137135 ↗
• MalfunctionJul 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT DURING INSERTION OF THE CAGE, ON IMPACT WITH MALLET INTO DISC SPACE, THE PEEK PORTION BROKE FROM TITANIUM PORTION. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081674 ↗
• MalfunctionJun 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR SPINAL STENOSIS. IT WAS REPORTED THAT WHILE GOING TO INSERT THE CAGE AND WHILE MALLETING THE CAGE IN THE PEEK PORTION OF THE CAGE SHEARED OFF. 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 14840534 ↗
• MalfunctionJun 17, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE CAGE DID NOT OPEN AND MADE WEIRD NOISES. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14727387 ↗
• MalfunctionApr 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A MDLIF PROCEDURE. IT WAS REPORTED THAT DURING SURGERY THE INTERBODY WAS LOADED ONTO THE INSERTER, AS THE PHYSICIAN WAS GOING TO PLACE THE INTERBODY INTO THE PATIENT, THE PEEK HINGE BROKE. THE PIECES WERE ACCOUNTED FOR NO BROKEN PIECE WERE IN THE PATIENT. THIS WAS CONFIRMED VIA X-RAY. AN ADDITIONAL INTERBODY WAS PLACED SUCCESSFULLY IN THE PATIENT. WHILE ADJUSTING THE SECOND INTERBODY, THE INSERTER WAS PLACED BACK INTO THE PATIENT AND LIGHTLY TAPPED, THE 2 SIDE METAL PIECES BROKE OFF, BUT WERE IMMEDIATELY SUCTIONED. THE METAL PIECES WERE CLEARLY SEEN IN SUCTION CONTAINER AND A DIFFERENT INSERTER WAS PROVIDED TO THE PHYSICIAN TO COMPLETE THE REST OF THE PROCEDURE. PRODUCT CAME IN CONTACT WITH THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14235496 ↗
• MalfunctionApr 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L5-S LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT, WHEN THE CAGE WAS INSERTED ON BOTH SIDES OF THE TITANIUM HEAD SIDE. THE DEVICE WAS INSTALLED ON THE LEFT SIDE WITHOUT ANY PROBLEMS, AND WHEN IT WAS INSERTED IN THE RIGHT SIDE, THE PROBLEM OCCURRED. THE CAGE WAS BROKEN WHEN IT WAS HIT ABOUT 5 TIMES WITH A HAMMER. THE BROKEN PART COULD NOT BE FOUND VISUALLY, SO IT WAS CLEANED. IT WAS UNKNOWN WHETHER IT WAS REMOVED OR NOT. THERE IS A POSSIBILITY THAT THE BROKEN PIECE IS STILL IN THE PATIENT'S BODY. AFTERWARDS, IT WAS REPLACED WITH A NEW CAGE AND INSERTED, THE INSTALLATION WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF PRODUCT MALFUNCTION.  THERE WAS NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED.  THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14139522 ↗
• MalfunctionApr 16, 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 LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT, THE CAGE WAS ATTACHED TO THE TIP OF THE INSERTER AND WAS DRIVEN IN WITH A HAMMER. A PART OF THE CAGE WAS BROKEN WHEN IT WAS DRIVEN IN WITH A HAMMER. THERE WAS NO FRAGMENT OF BROKEN CAGE REMAINS IN PATIENT BODY. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT AND NO HOSPITALIZATION REPORTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14126433 ↗