ELEVATE™ Spinal System 8657003Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169432192), received between May 13, 2019 and Jun 1, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A DEVICE US ED IN A SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353615 ↗
• MalfunctionFeb 10, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS FOUND TO HAVE A STRIPPED TIP, WAS NOT IN PROPER WORKING CONDITION, AND EXPERIENCED INSTRUMENT BREAKAGE. THE ISSUE WAS IDENTIFIED BY SURGICAL TECHNICAL STAFF PRIOR TO THE BEGINNING OF THE CASE, AND THE TIP OF THE INSERTER COULD NOT ENGAGE THE IMPLANT. THERE WAS NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301565 ↗
• MalfunctionApr 17, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT TRANSFORAMINAL INTERBODY LUMBAR FUSION(TLIF) FOR LUMBAR STENOSIS. IT WAS REPORTED THAT THE ELEVATE IMPLANT WAS ASSEMBLED ON THE INSERTER AND THE IMPLANT WAS INSERTED INTO THE DISC SPACE. THE SURGEON INSERTED THE INSERTER DRIVE SHAFT INTO THE INSERTER HANDLE AND BEGAN EXPANDING THE IMPLANT. THERE WAS RESISTANCE EXPERIENCED AS PER USUAL WHEN THE TORQUE LIMITING HANDLE REFUSED TO RELEASE AND THE INSERTER DRIVE SHAFT BROKE OFF INTO THE BACK END OF THE IMPLANT. THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. FOR THE TORQUE LIMITING HANDLE THERE WERE NO PHYSICAL BROKEN PIECES THAT COULD BE SEEN FROM THE OUTSIDE, BUT CLEARLY SOMETHING FAILED ON THE INSIDE THAT THE TORQUE LIMITING FEATURE DID NOT WORK. THERE WAS A SECOND INSERTER DRIVE SHAFT THAT WAS WORN. 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 16749056 ↗
• MalfunctionMar 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP BROKE OFF INSIDE IMPLANT DURING FINAL TIGHTENING. 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 16510166 ↗
• MalfunctionNov 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH NAVIGATED OPEN PO STERIOR LUMBAR FUSION THERAPY. LEVELS IMPLANTED L4-S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS L4-S1 DISC HERNIATION AND SPONDYLOSIS. IT WAS REPORTED THAT THE EXPANDER BROKE OFF INTO THE BACK UP THE IMPLANT AS IT WAS BEING EXPANDED. THE SURGEON ELECTED TO REMOVE THE IMPLANT AND RE-IMPLANT A NEW ONE. SURGEON PREPARED THE L4 DISC SPACE AS USUAL AND SIZED FOR THE ELEVATE IMPLANT. HE MEASURED 13MM, SO AS PER THE ELEVATE TECHNIQUE HE WAS GIVEN A 9MM ELEVATE IMPLANT (WHICH EXPANDS TO 13MM). WHEN SURGEON WAS EXPANDING THE IMPLANT HE GOT TO THE POINT OF RESISTANCE WHEN HE HEARD A SNAP, PULLED OUT THE EXPANDER AND THE TIP OF THE EXPANDER WAS BROKEN OFF. SO SURGEON REMOVED THE IMPLANT (STILL ATTACHED TO THE INSERTER), REMOVED THE IMPLANT, AS SAW THE TIP OF THE EXPANDER HAD BROKEN OFF INTO THE BACK OF THE IMPLANT. SURGEON OPENED ANOTHER IMPLANT AND USING THE SAME TORQUE LIMITING HANDLE AND A DIFFERENT EXPANDER SURGEON EXPANDED THE NEW IMPLANT. UPON HITTING RESISTANCE CONTINUED TO TURN THE TORQUE LIMITING HANDLE AND HEARD THE SAME SNAP, AND THE SECOND EXP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786817 ↗
• MalfunctionNov 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH NAVIGATED OPEN PO STERIOR LUMBAR FUSION THERAPY. LEVELS IMPLANTED L4-S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS L4-S1 DISC HERNIATION AND SPONDYLOSIS. IT WAS REPORTED THAT THE EXPANDER BROKE OFF INTO THE BACK UP THE IMPLANT AS IT WAS BEING EXPANDED. THE SURGEON ELECTED TO REMOVE THE IMPLANT AND RE-IMPLANT A NEW ONE. SURGEON PREPARED THE L4 DISC SPACE AS USUAL AND SIZED FOR THE ELEVATE IMPLANT. HE MEASURED 13MM, SO AS PER THE ELEVATE TECHNIQUE HE WAS GIVEN A 9MM ELEVATE IMPLANT (WHICH EXPANDS TO 13MM). WHEN SURGEON WAS EXPANDING THE IMPLANT HE GOT TO THE POINT OF RESISTANCE WHEN HE HEARD A SNAP, PULLED OUT THE EXPANDER AND THE TIP OF THE EXPANDER WAS BROKEN OFF. SO SURGEON REMOVED THE IMPLANT (STILL ATTACHED TO THE INSERTER), REMOVED THE IMPLANT, AS SAW THE TIP OF THE EXPANDER HAD BROKEN OFF INTO THE BACK OF THE IMPLANT. SURGEON OPENED ANOTHER IMPLANT AND USING THE SAME TORQUE LIMITING HANDLE AND A DIFFERENT EXPANDER SURGEON EXPANDED THE NEW IMPLANT. UPON HITTING RESISTANCE CONTINUED TO TURN THE TORQUE LIMITING HANDLE AND HEARD THE SAME SNAP, AND THE SECOND EXP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786812 ↗
• MalfunctionOct 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF WHILE FINAL TIGHTENING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697112 ↗
• MalfunctionFeb 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- LUMBAR BACKACHE INVOLVED IN THE PLIF PROCEDURE. LEVELS IMPLANTED: TH7/ILIAC. IT WAS REPORTED THAT INTRA-OPERATIVELY, IN PLIF OF L5 / S1, CAGE WAS INSERTED ON BOTH SIDES AND EXPANDED AT THE SAME TIME, THE TIP OF THE INSERTER DRIVE SHAFT USED ON THE RIGHT SIDE WAS BROKEN. FRAGMENT/TIP OF THE INSERTER DRIVE SHAFT REMAINS IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. REPORTED EVENT WAS REVISION SURGERY. NO MDT PRODUCTS USED IN THE INITIAL SURGERY. DATE OF INITIAL SURGERY (B)(6) 2019 PROCEDURE OR TECHNIQUE USED- L3/5 TLIF, TH10/11 PLIF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13568620 ↗
• MalfunctionJan 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER DRIVE SHAFT SHEERED OFF WHEN EXPANDING THE IMPLANT. THE IMPLANT WAS NOT LOOSE SO THE SURGEON DECIDED TO LEAVE THE IMPLANT IN PLACE WITHOUT REMOVING THE BROKEN PIECE WHICH SEEMED SECURELY IN PLACE IN THE BACK END OF THE IMPLANT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS LUMBAR STENOSIS. THERE IS ONLY ONE FRAGMENT WHICH IS TIGHTLY WEDGED INTO THE BACK END OF THE ELEVATE IMPLANT. THERE ARE NO PLANS TO SCHEDULE A REVISION SURGERY TO REMOVE THE FRAGMENT, AS THE FRAGMENT SEEMS SAFELY WEDGED INTO THE BACK OF THE IMPLANT. THE TORQUE HANDLE FAILED TO OPERATE PROPERLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13379996 ↗
• MalfunctionJan 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER DRIVE SHAFT SHEERED OFF WHEN EXPANDING THE IMPLANT. THE IMPLANT WAS NOT LOOSE SO THE SURGEON DECIDED TO LEAVE THE IMPLANT IN PLACE WITHOUT REMOVING THE BROKEN PIECE WHICH SEEMED SECURELY IN PLACE IN THE BACK END OF THE IMPLANT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS LUMBAR STENOSIS. THERE IS ONLY ONE FRAGMENT WHICH IS TIGHTLY WEDGED INTO THE BACK END OF THE ELEVATE IMPLANT. THERE ARE NO PLANS TO SCHEDULE A REVISION SURGERY TO REMOVE THE FRAGMENT, AS THE FRAGMENT SEEMS SAFELY WEDGED INTO THE BACK OF THE IMPLANT. THE TORQUE HANDLE FAILED TO OPERATE PROPERLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13379661 ↗
• MalfunctionJan 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND DID NOT TORQUE. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13364463 ↗
• MalfunctionDec 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE TIP BROKE IN CAGE. FRAGMENTS LEFT INSIDE THE PATIENT & COULD NOT BE RETRIEVED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE IS NO ANY ADDITIONAL SURGERY PLANNED TO REMOVE THE BROKEN TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13041580 ↗
• MalfunctionNov 18, 2021Break; 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 WORKING TIP OF THE EXPANSION SCREWDRIVER SNAPPED OFF INSIDE THE SCREW OF THE ELEVATE CAGE. IT WAS NOT REALIZED UNTIL THE INSTRUMENT WAS TAKEN OUT AND EXAMINED THE TIP. THERE WAS NO WAY TO EXTRACT THE SCREW TIP FROM THE CAGE, AND IT IS STILL IN THE PATIENT. THE ELEVATE CAGE MIGRATED AND PATIENT HAD LEG PAIN AND NUMBNESS. REVISION WAS PERFORMED TO PUT CAGE BACK INTO PLACE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12834046 ↗
• MalfunctionJun 30, 2021Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION DUE TO DEGENERATING DISC DISEASE CAUSING FORAMINAL STENOSIS. IT WAS REPORTED THAT WRONG HANDLE WAS ATTACHED TO THE EXPANDER. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091116 ↗
• MalfunctionMay 31, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT TIP OF DRIVER BROKE WHEN EXPANDING. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT BROKEN TIP WAS LODGED IN IMPLANT AND LEFT. THE PROCEDURE WAS TLIF L4-5.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11906853 ↗
• MalfunctionMar 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT SPINAL THERAPY FOR STENOSIS AT L4/5. IT WAS REPORTED THAT WHILE JACKING UP THE CAGE, THE DRIVER TIP PART BROKE BEFORE TORQUE WAS APPLIED. AS THE BROKEN PIECE COULD NOT FIT INTO THE CAGE, IT WAS IMPLANTED AS IT WAS. THERE WAS PATIENT INVOLVED IN THE EVENT AND FRAGMENTS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-FEB-16: THE BROKEN PART COULDN'T BE REMOVED FROM PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-MAR-03: THE LOT NUMBER WAS UNKNOWN AND PATIENT OUTCOME WAS REMISSION. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-MAR-05: THE BROKEN PART OF THE REPORTED PRODUCT REMAIN IN THE BODY AND COULD NOT BE REMOVED. OTHER PART OF THE PRODUCT WITHOUT THE BROKEN TIP WAS RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11431935 ↗
• InjuryAug 10, 2020Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING A L3-4-5-1 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL CORD STENOSIS. IT WAS REPORTED THAT THE DISTAL TIP BROKE AND WAS LEFT IN THE IMPLANT. PRODUCT WILL BE RETURNED, AND IT WILL BE REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY / COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10383560 ↗
• MalfunctionJul 6, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN INSERTER FOR A ROBOT ASSISTED LUMBAR INTERBODY FUSION WITH BI-LATERAL PLACEMENT OF ELEVATE INTERBODY DEVICES. IT WAS REPORTED THAT THE TIP OF INSTRUMENT BROKE WHILE EXPANDING DURING PROCEDURE. THE INSTRUMENT IN QUESTION WAS USED DURING THE PROCEDURE AND WAS USED TO SUCCESSFULLY EXPAND THE DEVICE. THE PRE-OP DIAGNOSIS WAS GRADE 1 SPONDYLOLISTHESIS WITH 4/5 STENOSIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10232222 ↗
• InjuryApr 22, 2020Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT DFI POSTERIOR LUMBAR DECOMPRESSION WITH FUSION AND INSTRUMENTATION AT L4-L5 AND L5-S1, WITH INTERBODY PROSTHESIS L5-S1, BMP, EBI AND ALLOGRAFT. INTRA-OP, THE TIP ON THE EXPANSION TOOL SNAPPED OFF INTO THE SCREW ON THE CAGE AND REMAINED IN THE BACK OF THE CAGE. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN WHETHER THERE WERE ANY COMPLICATION OR NOT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9986850 ↗
• InjuryDec 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION SURGERY AT L3-S1 DUE TO LUMBAR STENOSIS. INTRA-OP, SINCE THE TECH NURSE ASSEMBLED THE WRONG EGG HANDLE TO THE INSERTER AS A RESULT OF THAT WHEN SURGEON EXPANDED THE IMPLANT HE WAS EXPECTING THE TORQUE LIMITER TO CLICK, INSTEAD THE TIP OF THE INSTRUMENT SNAPPED OFF INTO THE BACK OF THE IMPLANTS. MANY ATTEMPTS WERE MADE TO TRY TO REMOVE IT, BUT WERE UNSUCCESSFUL. THE DOCTOR FELT THAT THE TIP WAS WELL EMBEDDED IN THE IMPLANT AND WOULD BE SAFE TO LEAVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9493727 ↗
• InjuryOct 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) AT L4-5 AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5-S1 DUE TO SPINAL CANAL STENOSIS. INTRA-OP, AFTER THE FIRST CAGE WAS INSERTED, THE CAGE WAS EXPANDED UNTIL THE COUNTER TORQUE IDLED. THEREAFTER, THE SURGEON REPLACED THE HANDLE WITH A FIXED EGG HANDLE FOR FURTHER EXPANDING, AND WHEN PERFORMING FURTHER EXPANDING, THE TIP OF THE INSERTER BROKE AND REMAINED IN THE CAGE. THIS BROKEN TIP SANK INTO THE SCREW ON THE CAGE SIDE, AND THE SURGEON JUDGED THAT IT WAS IMPOSSIBLE TO REMOVE THE TIP, THEN WOUND CLOSURE WAS PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9224067 ↗
• MalfunctionJul 25, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE INSTRUMENT TIP BROKE OFF WHILE EXPANDING THE CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8825204 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. INTRA-OP, THE TIP OF THE INSERTER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605412 ↗