ELEVATE™ Spinal System 8880923Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169430785), received between Apr 11, 2017 and Nov 24, 2025 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION FOR L5¿S1 HIVD (HERNIATED INTERVERTEBRAL DISC). IT WAS REPORTED THAT WHEN ATTEMPTING TO EXPAND THE CAGE, A FRACTURE OF THE CAGE WAS OBSERVED UNDER C-ARM FLUOROSCOPY. THE SURGEON REMOVED THE IMPLANT AND ALL ASSOCIATED FRAGMENTS COMPLETELY. A NEW CAGE WAS THEN OPENED, IMPLANTED, EXPANDED, AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. 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 23628405 ↗
• MalfunctionMar 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP), DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L4-5 HERNIATED INTERVERTEBRAL DISC. IT WAS REPORTED THAT, THE CAGE WAS BROKEN. AFTER DISCECTOMY, THE SURGEON CHOOSE THE PROPER SIZE AND ATTACHED THE IMPLANT. WHEN TRIED TO IMPACT THE IMPLANT INTO DISC SPACE, SURGEON FOUND THE CAGE RESISTANCE IN PUSHING. WHEN REMOVED THE CAGE IT WAS IDENTIFIED THAT THE CONJUNCTION OF PEEK AND TITANIUM WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE PATIENT BODY. THERE WAS NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500927 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SPACER. IT WAS REPORTED THAT THE SPACER WAS FOUND TO BE CRACKED BEFORE IT WAS IMPLANTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343956 ↗
• MalfunctionAug 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR DIAGNOSED L4-5 HIVD AND GRADE I SPONDYLOSIS. IT WAS REPORTED THAT THE CAGES WERE BROKEN. AFTER DISCECTOMY, THE SURGEON USED TRAIL TO DETERMINE THE SIZE OF IMPLANTS. THE SURGEON INSERTED IMPLANT INTO THE SPACE. WHEN THE HAMMER WAS USED TO HIT THE INSERTER, THE CAGE WAS BROKEN. THEN THE SURGEON REMOVED THE CAGE AND REPLACED WITH THE NEW ONE. HE REPEATED THE SAME PROCEDURE AND CAGE WAS BROKEN. HE REPLACED THE THIRD CAGE AND FINISHED 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 19904369 ↗
• MalfunctionMay 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/S1 RIGHT SIDE TLIF FOR RIGHT L5 NERVE ROOT STENOSIS. IT WAS REPORTED THAT DURING CAGE INSERTION A PIECE FROM THE SUPERIOR SIDE OF THE IMPLANT WAS VIEWED AS BREAKING OFF INTO THE L5/S1 INTRADISCAL SPACE. THE CAGE WAS STILL FIRMLY ATTACHED TO THE INSERTER AND WAS REMOVED. THE PIECE OF IMPLANT VIEWED TO HAVE BROKEN OFF THE IMPLANT WAS ALSO REMOVED. 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 19379694 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED IN L4/5 PLIF THERAPY FOR LSCS. IT WAS REPORTED THAT AN INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. ALL L4/5 WAS FOUND DISCONNECTED DURING SURGERY. HOWEVER, A BONE TRANSPLANT WAS PERFORMED AS IS AND A CAGE WAS INSTALLED. UPON CHECKING THE POSTOPERATIVE IMAGES, IT WAS FOUND OUT THAT THE CAGE IS DISLODGING FORWARD. AN OLIF WAS PERFORMED (REVISION SURGERY) ON (B)(6) 2023. THE REPORTED CAGE WAS REMOVED AND REPLACED WITH AN ANTERALINE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730523 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED IN L4/5 PLIF THERAPY FOR LSCS. IT WAS REPORTED THAT AN INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. ALL L4/5 WAS FOUND DISCONNECTED DURING SURGERY. HOWEVER, A BONE TRANSPLANT WAS PERFORMED AS IS AND A CAGE WAS INSTALLED. UPON CHECKING THE POSTOPERATIVE IMAGES, IT WAS FOUND OUT THAT THE CAGE IS DISLODGING FORWARD. AN OLIF WAS PERFORMED (REVISION SURGERY) ON (B)(6) 2023. THE REPORTED CAGE WAS REMOVED AND REPLACED WITH AN ANTERALINE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730473 ↗
• MalfunctionFeb 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L4. IT WAS REPORTED THAT, THE CAGE WAS LARGE FOR INITIAL IMPLANTATION. BROKE IN HALF (PLASTIC AND TITANIUM SEPARATION) BEFORE ENTERING THE DISC SPACE UPON MALLETING. PATIENT PRESENTED WITH A TIGHT L3-4 DISC SPACE. USED DISC PREPARATION INSTRUMENTS, KERRISONS, AND DRILL TO ADEQUATELY PREPARE SITE FOR IMPLANTATION. UPON MALLETING IMPLANT, THE PEEK AND TITANIUM COMPONENTS SPLIT APART INTO TWO PIECES AT THE CONNECTION. THE IMPLANT SPLIT INTO TWO DISTINCT AND WHOLE PIECES AND WAS DISCARDED BY STAFF. THE DISC SPACE WAS THEN FILLED WITH A STATIC 10MM HEIGHT X 22MM LENGTH CAPSTONE CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406821 ↗
• InjuryAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SPINAL THERAPY FOR LUMBAR CANAL STENOSIS (LCS) AT L4/5. IT WAS REPORTED THAT AFTER INSTALLING THE PLIF AND L5 PS, IT WAS CONFIRMED THROUGH FLUOROSCOPY THAT THE RIGHT CAGE WAS MOVING IN THE ANTERIOR DIRECTION WHEN THE DEVICE WAS OPERATED FOR REPAIRING THE DURA. IMMEDIATELY, USING THE REMOVAL PERIOD, THE CAGE WAS PICKED UP, BUT THE ENTRANCE WAS NARROW AND COULD NOT BE REMOVED EASILY. LOOKING AT THE FLUOROSCOPY AGAIN, IT WAS DETERMINED THAT THE CAGE WAS MOVING FORWARD ON ITS OWN THAN BEFORE, AND FURTHER OPERATION FROM THE REAR WAS DANGEROUS. THE PLAN WAS CHANGED TO COLLECT THE CAGE FROM THE FRONT. ADDED AN L4 SCREW AND L4/5 FIXATION WAS COMPLETED AND THE SURGICAL INCISION WAS CLOSED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS A DELAY OF MORE THAN 60 MINUTES DUE TO THE ADDITIONAL TREATMENT WAS PERFORMED BY CHANGING THE PATIENT POSITION FOR THE REMOVAL OF CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200924 ↗
• MalfunctionApr 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT L4-5 POS TERIOR LUMBAR INTERBODY FUSION (PLIF) SPINAL THERAPY. IT WAS REPORTED THAT WHEN PHYSICIAN TRIED TO REMOVE THE CAGE FROM THE TIP, THE TITANIUM AND PEEK PARTS CAME OFF. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WAS ATTEMPTED TO INSERT ONCE AND NOTICED THAT THE PRODUCT WAS BROKEN. THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13974466 ↗
• MalfunctionJan 16, 2021Mechanics Altered; Patient Device Interaction Problem; Mechanics Altered; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SPONDYLOLYTIC SPONDYLOLISTHESIS INVOLVED IN 5/SPLIF PROCEDURE. LEVELS IMPLANTED- L5/S. IT WAS REPORTED THAT EVENT OCCURRED DURING SURGERY, WHEN THE CAGE WAS STUFFED WITH BONE. AFTER FILLING THE CAGE WITH BONE FOR INSERTION INTO THE PATIENT, IT WAS CONFIRMED THAT THE CAGE DID NOT DILATE/EXPAND WHEN IT WAS CHECKED TO SEE IF IT COULD BE DILATED. HENCE, CAGE WAS NOT IMPLANTED IN THE PATIENT. THE PRODUCT WAS REPLACED WITH A NEW CAGE. EVENT WAS ASSOCIATED WITH THE PATIENT. REPORTED, IT SEEMED THAT THERE WAS A PIECE OF BONE IN THE SCREW PART, WHEN THEY TRIED TO REMOVE THE BONE FROM THIS CAGE AFTER SURGERY, IT SEEMED THAT THE BONE WAS STUCK IN THE SCREW. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THE EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182542 ↗
• MalfunctionAug 26, 2020Fracture; Fracture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE FOR A TLIF. IT WAS REPORTED THAT THE CAGE FRACTURED WHILE BEING IMPACTED. SURGEON NOTICED THAT IT HAPPENED AND REMOVED IT. HE REPLACED IT WITH ANOTHER CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS NO FRAGMENT LEFT BEHIND IN THE PATIENT'S BODY. THE PRE-OP DIAGNOSIS WAS SPONDYLOLISTHESIS GRADE 2 WITH STENOSIS AND RADICULOPATHY. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

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

  MAUDE report 10457919 ↗
• MalfunctionFeb 18, 2020Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO MALLET IN THE CAGE IT BROKE INTO TWO PIECES DURING IMPLANTATION. CAGE WAS COLLAPSED FULLY BEFORE IMPLANTATION AND THEN PACKED WITH GRAFTING MATERIALS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9719467 ↗
• InjurySep 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) AT L4-5. POST-OPERATIVELY, THE CAGE WAS DEVIATED. ABOUT TWO THIRDS OF THE CAGE CAME OFF TOWARDS THE ANTERIOR SIDE OF THE VERTEBRAL BODY. REVISION SURGERY WAS PERFORMED AS THERE WAS A POSSIBILITY THAT THE CAGE COULD FALL TOWARDS THE VENTRAL SIDE. THE CAGE WAS REMOVED FROM THE POSTERIOR SIDE BECAUSE IT WAS NOT IN CONTACT WITH THE UPPER END PLATE. THE SURGEON REMOVED THE CAGE AFTER INSERTING AN INSERTER SHAFT. AFTER CAGE REMOVAL, GRAFTED BONE WAS ADDED. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8989939 ↗
• MalfunctionJul 13, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, CAGE BROKE DURING IMPLANTATION. CAGE WAS BEING INSERTED INTO PATIENT'S COLLAPSED VERTEBRA WHEN THE INCIDENT OCCURRED. THE BROKEN CAGE WAS COMPLETELY REMOVED AND REPLACED WITH A CAGE OF SMALLER SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8787392 ↗
• MalfunctionNov 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L5-S1 LEVELS. DURING SURGERY, THE SPACER BROKE DURING INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE SPACER REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8036742 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MIS TLIF (MINIMALLY-INVASIVE SURGICAL TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY DUE TO DEGENERATIVE DISC. INTRA-OP, PEEK PORTION OF CAGE WAS BROKEN AND WOULD NOT ALLOW US TO FULL SEAT THE IMPLANT IN THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863624 ↗
• MalfunctionAug 30, 2018Break; Break

  PRE-OP DIAGNOSIS: REVISION/EXTENSION OF PREVIOUS LUMBAR FUSION PROCEDURE: REVISION/EXTENSION OF LUMBAR SPINE FUSION IT WAS REPORTED THAT INTRA-OP, DURING ATTEMPTED IMPLANTATION INTO PREPARED L5-S1 DISC SPACE, PEEK PORTION OF IMPLANT SEPARATED FROM TITANIUM PORTION OF IMPLANT. BROKEN IMPLANT IMMEDIATELY REMOVED FORM SURGICAL SITE BY SURGEON. REPLACEMENT IMPLANT SUBSEQUENTLY IMPLANTED BY SURGEON WITHOUT PROBLEM. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7835445 ↗
• MalfunctionAug 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMAL ACCESS SPINAL TRANSFOFAMIAL LUMBAR SPINAL FUSION SURGERY AT L4-5 DUE TO SPONDOLOLYSTESIS. INTRA-OP, THE CAGE BROKE DURING IMPACTION OF IMPLANT INTO THE DISC SPACE, UNDER FLUOROSCOPY, INDICATED THAT THE UPPER PORTION OF DEVICE HAD DISCONNECTED OR BROKEN AWAY FROM TITANIUM PART OF THE DEVICE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778214 ↗
• MalfunctionDec 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, THE CONNECTION PART OF PEEK PART AND TITANIUM PART OF THE CAGE WAS FOUND TO BE BROKEN. FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7150441 ↗
• MalfunctionOct 17, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) DUE TO STENOSIS. DURING INSERTION, THE SPACER BROKE. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953930 ↗
• MalfunctionSep 25, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L4/5 DUE TO SPONDYLOLISTHESIS AT L4. DURING THE SURGERY, SPINAL CAGE WAS BROKEN WHILE IT WAS HAMMERED. WHEN THE CAGE WAS FILLED WITH GRAFTED BONE, THE ANTERIOR OF THE CAGE WAS FOUND TO BE OPEN. AT THAT POINT, IT HAD BEEN VISUALLY CHECKED THAT THE SCREW THAT OPENS THE REAR OF CAGE WAS NOT TURNED, SO THE OPEN PART WAS CLOSED WITH THE SURGEON¿S HANDS AND IT WAS INSERTED. AS THERE WAS A TILT OF THE VERTEBRAE LIKE L5/S ANGLE, THE ANTERIOR OF THE CAGE WAS OPENED AGAIN DURING INSERTION AND WAS BROKEN. THE SURGICAL SITE WAS THOROUGHLY CLEANED, BUT IT WAS UNKNOWN WHETHER THE FRAGMENT(S) WAS LEFT OVER OR NOT. WHEN THE RELEVANT CAGE WAS UNPACKED, IT SEEMED NOT TO BE ELEVATED, AND TO HAVE ITS SCREW PROTRUDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6889455 ↗
• MalfunctionSep 12, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, THE IMPLANTS BROKE UPON IMPACTION INTO L2-3 DISC SPACE. AFTER THE 9MM X 23MM CAGE BROKE, AN 8MM X 23MM CAGE WAS IMPLANTED INTO THE DISC SPACE WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6857327 ↗
• MalfunctionSep 12, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, THE IMPLANT BROKE UPON IMPACTION INTO L3-4 DISC SPACE. AFTER THE 9MM X 23MM CAGE BROKE, AN 8MM X 23MM CAGE WAS IMPLANTED INTO THE DISC SPACE WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6857324 ↗
• MalfunctionApr 11, 2017Break; Break

  IT WAS REPORTED PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3-5. INTRA-OP, THE SURGEON IMPLANTED TWO CAGES ON LEVEL L4-5 AND ONE WAS IMPLANTED ON L3-4.WHILE ATTEMPTING TO IMPLANT SECOND ELEVATED CAGE ON L3-4, THE CAGE BROKE, BREAKING OFF A SMALL PART OF THE PEEK SIDE.NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATION WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479580 ↗