T2 STRATOSPHERE Expandable Corpectomy System 436120CRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169634862), received between Dec 26, 2019 and Feb 9, 2024 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Migration” (10 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.

• MalfunctionFeb 9, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING V ERTEBRAL REPLACEMENT DUE TO L3 VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHEN THE T3 WAS JACKED UP, IT BECAME HARD AND COULD NOT BE CARRIED UP ANY FURTHER. THE SAME SITUATION WAS OBSERVED WHEN IT WAS REMOVED FROM THE BODY FOR CONFIRMATION. AFTER REPEATING SEVERAL TIMES, IT COULD BE FIRMLY EXTENDED, SO IT WAS JACKED UP AGAIN INSIDE THE BODY, BUT THE SAME THING HAPPENED AND THE IMPLANT WAS REPLACED WITH A NEW ONE. THE NEW IMPLANT WAS ABLE TO BE RAISED SMOOTHLY AND PLACED IN THE VERTEBRAL BODY WITHOUT ANY PROBLEM. IT CAN BE SURMISED THAT IT WAS A STRUCTURAL PROBLEM WITH T3. 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 18674216 ↗
• MalfunctionMay 15, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR L1 RUPTURED FRACTURE, T11-L2+HOOK WAS USED FOR POSTERIOR FIXATION WITH SOLERA 5560 ON 4/11. 4/18 ANTERIOR VERTEBRAL BODY REPLACEMENT IT WAS REPORTED THAT THE DURING T2-S INSTALLATION, THE CENTER SET SCREW CAME OFF WHILE REPEATING THE PROGRESS AND TEMPORARY FIXATION SEVERAL TIMES. CENTER SET SCREW DISLODGEMENT. THE REPLACED T3 CAN BE INSTALLED WITHOUT ANY PROBLEMS. RETURN THE CAGE WITH THE SET SCREW THAT CAME OFF. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME OF LESS THAN 60 MINUTES. NO, ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928467 ↗
• MalfunctionMar 31, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR NEUROLOGICAL SYMPTOMS ASSOCIATED WITH L3 CRUSHING. PROCEDURE PERFORMED WAS PERIODIC ANTERIOR-POSTERIOR FIXATION/POSTERIOR FIXATION + ANTERIOR RECONSTRUCTION. LEVEL AT WHICH THE IMPLANT WAS PERFORMED L2/3/4. IT WAS REPORTED THAT THE IMPLANT LATERALLY DEVIATED DURING THE INITIAL MEDICAL CONSULTATION. IT WAS ALSO CONFIRMED THAT THE SLOPE OF THE EXTEND END CAP HAD CHANGED WHILE IT DEVIATED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO REVISION SURGERY WILL BE PERFORMED IN FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653740 ↗
• MalfunctionMar 30, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN VERTEBRAL BODY REPLACEMENT SPINAL THERAPY FOR L4 BURST. IT WAS REPORTED THAT FINAL FASTENING COULD NOT BE DONE ON THE EXTENSION PART. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CAGE WAS INSERTED, JACKED UP, AND FINALLY FASTENED. AFTER THE FINAL FASTENING, THE CAGE CONTRACTED WHEN THE SCREWDRIVER WAS ROTATED BACKWARD A LITTLE TO MAKE SURE IT DID NOT MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642041 ↗
• MalfunctionMar 28, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT AND CAP USED IN PRIMARY ANTERIOR AND POSTERIOR FUSION/POSTERIOR FUSION + ANTERIOR RECONSTRUCTION THERAPY FOR NEUROLOGICAL SYMPTOMS ASSOCIATED WITH L3 CRUSHING. LEVELS IMPLANTED: L2/3/4 IT WAS REPORTED THAT AFTER DISCHARGE FROM THE HOSPITAL, IT WAS CONFIRMED THAT THE IMPLANT LATERALLY DEVIATED DURING THE INITIAL MEDICAL CONSULTATION. IT WAS ALSO CONFIRMED THAT THE SLOPE OF THE EXTENDENDCAP HAD CHANGED WHILE IT DEVIATED. NO ADDITIONAL SURGERY/TREATMENT IS PLANNED AND NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626504 ↗
• MalfunctionMar 24, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING VERTEBRAL REPLACEMENT FOR LUMBAR BURST FRACTURE. IT WAS REPORTED THAT THE ENDO CAP WAS BACK-OUT BY ABOUT 1/4 OF THE END CAP AFTER THE SURGERY, AND THE ANGLE OF THE ENDO CAP WAS MOVING IMMEDIATELY AFTER THE SURGERY. NO PATIENT SYMPTOMS OR COMPLICATIONS BECAUSE OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT CT SCAN AT POSTOPERATIVE FOLLOW-UP SHOWED A CAUDAL ENDPLATE FRACTURE. THE ANGLE OF THE CAUDAL END CAP HAD CHANGED AND BONE QUALITY SEEMS POOR. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608493 ↗
• MalfunctionOct 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CORPECTOMY. IT WAS REPORTED THAT THE PINION BROKE WHILE DISTRACTING. IT COULD NOT BE DISTRACTED AFTER BREAKING. NO FRAGMENT WAS LEFT IN THE PATIENT. THE PRODUCT CAME IN 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 15593192 ↗
• MalfunctionMay 31, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL BODY REPLACEMENT (ANTERIOR APPROACH). THE PRE-OP DIAGNOSIS WAS MENTIONED AS L1 VERTEBRAL FRACTURE. IT WAS REPORTED THAT, IMPLANT BACK-OUT IS BEING CONFIRMED AFTER THE SURGERY. UPON CHECKING THE IMAGE, IT SEEMS THAT THE SELF-ADJUSTING ENDO CAP ON THE UPPER END PLATE SIDE OF L2 IS MOVING DESPITE THE FINAL TIGHTENING. THE CAGE WAS DISLOCATED APPROXIMATELY 1 WEEK AFTER THE PROCEDURE. IT SEEMS THAT THE ENDO CAP IS MOVING. THE END PLATE IS FRACTURED. THE LEVELS IMPLANTED WERE L1. NO REVISION SURGERY IS PLANNED TO EXPLANT. THERE WAS NO SYMPTOMS OR COMPLICATIONS REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546717 ↗
• MalfunctionMar 7, 2022Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FUSION SPINAL THERAPY FOR T12 VERTEBRAL BODY REPLACEMENT AT T10-L2. IT WAS REPORTED THAT THE SET SCREWS WAS LOOSENED IN TWO PLACES, SET THE PRODUCT ON THE INSERTER, AND EXPANDED IT, BUT IT DID NOT EXPAND. WHEN THEY REMOVED THE PRODUCT AND PULLED IT BY HAND, IT EXPANDED, SO THEY SET THE PRODUCT ON THE INSERTER AGAIN AND EXPANDED IT, BUT IT COULD NOT BE EXPANDED. IT WAS A BURST CASE OF L1 INSTEAD OF T12. THE POSTERIOR FUSION IS AT T11-L3. 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 13681641 ↗
• MalfunctionFeb 25, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR FIRST LUMBAR BURST FRACTURE. IT WAS REPORTED THAT THE PRODUCT CONTRACTED AFTER PLACING IT INTO T3 AND FINAL FIXING WAS PERFORMED. THEY HAD TO REINSERT A NEW IMPLANT AND COMPLETED THE PROCEDURE. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE ENDCAPS HAVE NO MALFUNCTION. EVEN IF THE CENTERPIECE WAS EXPANDED, IT COULD NOT BE FIXED IN THE EXPANDED STATE. WHEN IT WAS TOOK OUT OF THE SURGICAL FIELD AND FIXED WITH THE SET SCREW WITHOUT STRESS, IT COULD NOT MAINTAIN THE EXPANDED STATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598539 ↗
• InjuryJan 10, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CENTERPIECE. PROCEDURE PERFORMED WAS TWO STAGES OPERATION, AFTER PERFORMING POSTERIOR FUSION OF T10-L3, CORPECTOMY OF L1 WAS PERFORMED BY ANTERIOR FUSION, T3 WAS PLACED, AND OLIF WAS PERFORMED AT L2 / 3. IT WAS REPORTED THAT POST-OPERATIVELY, DUE TO THE BACK-OUT OF THE IMPLANT, A REOPERATION WAS PERFORMED, AND THE IMPLANT WAS REMOVED, AND THE ILIUM WAS PLACED. SINCE T3 HAD BACKED OUT, IT WAS REMOVED, AND ILIAC BONE GRAFTED FROM THE ANTERIOR SIDE. COMPARED TO IMMEDIATELY AFTER THE OPERATION, THE SELF-ADJUSTING CAP WAS TILTED IN THE IMAGE ONE WEEK LATER, AND THE LEFT SIDE ON THE APPROACH SIDE WAS BACKED OUT. IN ADDITION, THERE WAS NO INFORMATION ON FRACTURES OF THE BACKED OUT UPPER AND LOWER VERTEBRAL BODIES AT THIS TIME, BUT IT WAS SAID THAT IT IS A PATIENT WITH OSTEOPOROSIS. THE CENTERPIECE WAS BACKED OUT AT L1. CENTERPIECE WAS EXPLANTED IN THE REVISION SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202702 ↗
• MalfunctionNov 25, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT BEFORE FILLING THE CAGE WITH THE TRANSPLANTED BONE, THE PRODUCT DID NOT RISE AT ALL, AND IT WAS STIFF. THERE WAS NO CHANGE EVEN THOUGH THE PRODUCT WAS REMOVED FROM THE INSERTER AND THEN REATTACHED. THE SAME EVENT OCCURRED EVEN THOUGH THE SECOND ARRANGED PRODUCT OF THE SAME SIZE WAS TAKEN OUT AND WAS SLIGHTLY EXPANDED. WHEN THEY CHECKED THE REPORTED DEFECTIVE PRODUCT, THE SET SCREW THAT LOCKS THE EXPANSION IN THE CENTER OF THE CAGE WAS SO STIFF. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THE PATIENT SYMPTOMS AS A RESULT OF THIS EVENT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873605 ↗
• InjuryJul 15, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3 VERTEBRAL BODY REPLACEMENT SURGERY DUE TO VERTEBRAL FRACTURE. THE PATIENT WAS SCHEDULED TO HAVE AN OPERATION THAT SET T3 AT L3 AND PERFORM OLIF AT L4/5 ON (B)(6) AND PERFORM PLIF AT L5/S AND POSTERIOR FIXATION ON (B)(6). DURING HOSPITALIZATION AFTER (B)(6) 2020 OPERATION, THE PATIENT WORE A CORSET AND WALKED TO A SEATED MEAL AND THE TOILET. POSTOPERATIVE PHOTOGRAPH WAS TAKEN ON (B)(6) 2020 AND IT SEEMED THAT THE IMPLANTED END CAP WAS ALREADY TILTED COMPARED TO THE STATE DURING SURGERY. ON (B)(6), WHILE TAKING RADIOGRAPHIC IMAGE DURING THE PREOPERATIVE DIAGNOSIS, IT WAS FOUND THAT THE IMPLANTED CAGE HAD BACKED OUT/MIGRATED. THE ANGLE OF THE END CAP HAD CHANGED. IN THE OPERATION PERFORMED ON (B)(6) 2020, IT WAS PLANNED TO PERFORM PLIF AT L5/S AND POSTERIOR FIXATION, BUT IT WAS NECESSARY TO REPLACE THE T3 CAGE, SO THE CAGE WAS REPLACED. IT WAS POSSIBLE THAT THE CONTRALATERAL DISC CURETTAGE WAS NOT PERFORMED PERFECTLY, BUT AS PER THE SURGEON OPINION, THE VERTEBRAL BODY WAS RAISED WELL DURING THE INTRA-OPERATIVE LENGTHENING.

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

  MAUDE report 10274612 ↗
• MalfunctionJun 20, 2020Material Integrity Problem; Activation Failure; Material Integrity Problem; Activation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT OF L1 VERTEBRAL BODY. ROD REMOVAL WAS ALSO PERFORMED DURING THIS SURGERY AS THE PREVIOUSLY IMPLANTED ROD (MANUFACTURED BY STRYKER) HAD BROKEN. AFTER REMOVING THE BROKEN ROD AT THE POSTERIOR SIDE, REPLACEMENT OF VERTEBRAL BODY WAS PERFORMED FROM THE ANTERIOR SIDE. THEN, INSERTION OF CAGE WAS PERFORMED. THE CAGE HAD BEEN HAMMERED STRONGLY WHICH MAY BE DUE TO THE BONES HAD INTERFERED A LITTLE AS THE CURETTING WAS NOT PERFORMED PERFECTLY. AFTER INSERTION, THE REPORTED CAGE DID NOT EXPAND AND THE DRIVER IDLED. SO, THE CAGE WAS REMOVED. THE ALLEGED CAGE WAS CHECKED AT THE TIME OF OPENING THE PACKAGE AND AFTER BEING REMOVED FROM PATIENT'S BODY, AND IT EXPANDED AT BOTH INSTANCES. A NEW CAGE WAS HOWEVER USED TO COMPLETE THE PROCEDURE. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE, THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. WHEN THE CAGE WAS CHECKED, THE POST GEAR WAS FOUND CHIPPED, AND THE INSERTER CONNECTION WAS SCRATCHED. IT COULD PUT ON THE INSERTER AND EXTEND IT, BUT IT WAS OFTEN SPINNING AROUND WHERE THE GEAR HAD CHIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10177111 ↗
• InjuryMay 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4 OSTEOPOROTIC VERTEBRAL FRACTURE. THE PATIENT ALSO HAD DEGENERATIVE LUMBAR SCOLIOSIS, THE BONE QUALITY WAS WEAK AND THE UPPER END PLATE OF L5 HAD INJURY. THE PATIENT UNDERWENT REPLACEMENT OF L4 VERTEBRAL BODY AND ANTERIOR FIXATION. PERCUTANEOUS PEDICLE SCREW FIXATION (PPS) WAS PERFORMED, WITH ANOTHER MANUFACTURER PRODUCTS, FROM THE POSTERIOR APPROACH. THREE DAYS, POST-OP, THE IMPLANTED CAGE BACKED OUT. IT WAS CONFIRMED THAT THE UPPER END PLATE OF L5 WAS IN A SHAPE THAT IT WAS SINKING DIAGONALLY (THE ENTRY SIDE WAS WIDE AND THE CONTRALATERAL SIDE WAS NARROW). THE POSTERIOR PPS, WHICH WAS PERFORMED USING ANOTHER MANUFACTURER PRODUCTS, WAS ALSO EVALUATED AS UNSATISFACTORY IN EFFICACY. THE PATIENT DID NOT HAVE ANY SYMPTOMS, AND THE SYMPTOMS HAD RECOVERED COMPARED TO BEFORE THE OPERATION, BUT THE PATIENT WAS EVALUATED AS UNABLE TO WITHSTAND REHABILITATION. HENCE, IT WAS DECIDED TO PERFORM A RE-OPERATION. PATIENT UNDERWENT REVISION SURGERY FOR CAGE REMOVAL, AND FIXATION WAS PERFORMED AGAIN. THE CAGE WAS REPLACED WITH ANOTHER ONE OF SIZE C FROM ANTERIOR SIDE; AND PLACEMENT WAS DONE WITHOUT PROBLEMS.

  Patient problems: Erosion

  MAUDE report 10027829 ↗
• MalfunctionApr 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4 OSTEOPOROTIC VERTEBRAL FRACTURE; AND UNDERWENT REPLACEMENT OF L4 VERTEBRAL BODY. ANTERIOR APPROACH WAS PERFORMED TO REPLACE THE L4 VERTEBRA. INTRA-OP, AFTER PLACING THE IMPLANT, THE INSERTER COULD NOT BE REMOVED; AND THE CAGE CAME OFF. WHEN AN ATTEMPT WAS MADE TO LOOSEN USING THE DRIVER IN ORDER TO TURN THE END PLATE ANGLE BACK, THE ADJUSTABLE END PLATE PART OF THE IMPLANT BROKE. THEN, THE BROKEN IMPLANT WAS REPLACED WITH ANOTHER ONE. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT; BUT NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9932360 ↗
• InjuryMar 25, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBRAL BODY ANTERIOR REPLACEMENT AT L2 DUE TO COMPRESSION FRACTURE OF VERTEBRAL BODY. POST-OP, IT WAS FOUND THAT THE CAGE HAS BACKED OUT BY CHECKING X-RAY IMAGE AFTER 2 WEEKS OF OPERATION. THE PATIENT WAS ABLE TO WALK WITH A CANE AND THERE WAS NO HEALTH DAMAGE IN THE PATIENT AT THIS POINT. HOWEVER, IT WAS CHECKED BY IMAGE THAT THE EXTENDED ENDCAP HAS CONTACTED WITH THE KIDNEY AND IT WAS FORECASTED THAT SERIOUS DAMAGE WILL OCCUR IF THE CAGE CONTACTS WITH THE ANTERIOR MAJOR BLOOD VESSEL. BONE QUALITY WAS VERY BAD. IT WAS FOUND BY CHECKING THE X-RAY IMAGE TAKEN IN THE FIRST WEEK AFTER THE OPERATION THAT THE VERTEBRAL BODY OF THE MOST UPPER LEVEL FRACTURED. MAYBE THE SCREW AT L4 LOOSENED. HENCE AN REVISION SURGERY PERFORMED ON (B)(6) 2020 IN WHICH ALL OF THE SCREWS ON THE POSTERIOR SIDE WERE REMOVED AND TO REPLACE THE SCREWS WITH THICK SCREWS AND AFTER THAT, RETRIEVE THE CAGE WHICH BACKED OUT TO THE ANTERIOR SIDE AND TO INSERT AUTOLOGOUS BONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9881752 ↗
• InjuryMar 16, 2020Migration; Migration

  PRE OP DIAGNOSIS: COMPRESSION FRACTURE PROCEDURE PERFORMED: ANTERIOR VERTEBRAL BODY REPLACEMENT AND POSTERIOR FIXATION WERE PERFORMED POST OP, AFTER T3 INSERTION, COMPRESSION FRACTURE OCCURRED AT L3 DUE TO WHICH THE IMPLANTED CAGE SANK AND BACKED OUT. THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE FIXATION RANGE OF POSTERIOR FIXATION WAS CHANGED FROM 1 ABOVE-1 BELOW TO 3 ABOVE-2 BELOW. AUTOGRAFT WAS PLACED WHERE CORPECTOMY WAS PERFORMED, AND THEN THE OPERATION WAS FINISHED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9834332 ↗
• InjuryMar 11, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR VERTEBRAL BODY REPLACEMENT AT L2 DUE TO BURST FRACTURE. POST-OP, T3 BACKED OUT AFTER IT WAS INSERTED. HENCE ON (B)(6) 2020, DURING REVISION SURGERY, A PATIENT POSITION WAS TAKEN AND IT WAS CONFIRMED BY CHECKING THE IMAGE THAT THE IMPLANT HAS NOT BEEN IN CONTACT WITH THE ENDPLATE ON THE CRANIAL SIDE AT ALL. IT WAS PERFORMED AFTER POSTERIOR FIXATION. THE REASON CONSIDERED FOR BACKING OUT WERE THE POSTERIOR SCREW LOOSENED, AND THE ANTERIOR SIDE OPENED. THE T3 SHRANK AFTER THE OPERATION. THE THIRD IMAGE WAS THE IMAGE THAT WAS TAKEN IMMEDIATELY AFTER THE OPERATION. THE FRONTAL IMAGE RIGHT AFTER THE OPERATION WAS NOT AVAILABLE, BUT IT WAS CONSIDERED THAT THE POSITION WHERE THE CAGE WAS PLACED HAD DEVIATED A LITTLE FROM THE CENTER OF THE VERTEBRAL BODY. IT WAS FOUND THAT IT HAS TURNED TO THE STATE OF THE FIRST IMAGE THREE OR FOUR DAYS AFTER THE INITIAL SURGERY. THE SECOND IMAGE WAS TAKEN DURING THE REVISION SURGERY. WHEN THE IMPLANT WAS PLACED FOR THE FIRST TIME, IT IS UNKNOWN AT THIS POINT THAT THE IMPLANT HAS SHRUNK OR THE ADJUSTABLE END CAP WAS DEVIATED. ACCORDING TO SURGEON MAY BE L3 HAD HAVE COMPRESSION FRACTURE(IT WAS UNKNOWN WHEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9822049 ↗
• InjuryFeb 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L1 PSEUDOARTHROSIS; AND UNDERWENT REPLACEMENT OF VERTEBRAL BODY BY ANTERIOR APPROACH. PLACEMENT OF CAGE WAS PERFORMED AT L1 IN THE FIRST STAGE SURGERY; AND OBLIQUE LUMBAR INTERBODY FUSION WAS PERFORMED AT L2-L3. NO COMPLICATIONS OR MALFUNCTIONS WERE REPORTED AFTER THIS SURGERY. THE SECOND STAGE OF SURGERY WAS TO BE PERFORMED ON (B)(6) 2019. ON THE WEEKEND AFTER THE FIRST STAGE SURGERY, IT WAS REPORTED THAT THE PATIENT KICKED THE NURSE WITH SEVERE SYMPTOMS OF DELIRIUM. IN THE MORNING OF (B)(6) 2019, THE SURGEON WAS WORRIED AND X-RAYS TAKEN BEFORE THE OPERATION REVEALED THAT THE CAGE SANK TOWARDS L2 ENDPLATE AND THE SUPERIOR ENDPLATE OF L2 FRACTURED. THERE WAS A POSSIBILITY THAT THE L2 SUPERIOR ENDPLATE GOT FRACTURED BECAUSE OF THE CAGE BACK-OUT. BONE QUALITY OF THE PATIENT WAS WEAK. IT WAS UNKNOWN EXACTLY WHAT THE CAUSE WAS, BUT IT SEEMED THAT THE ANGLE OF THE SELF-ADJUSTING END CAP HAD CHANGED. SINCE IT WAS NOT A MAJOR BACK-OUT, ONLY THE SECOND STAGE SURGERY WAS PERFORMED (AS IT WAS PLANNED). POSTERIOR FIXATION WAS PERFORMED AT T10-L4. FOLLOW-UP OBSERVATIONS WERE PLANNED FOR THE PATIENT. AT THE END OF (B)(6), NO FURTHER BACK-OUT OF TH

  Patient problems: Bone Fracture(s); Confusion/ Disorientation

  MAUDE report 9689209 ↗
• InjuryJan 15, 2020Migration; Migration

  LEVELS IMPLANTED: L3-5 IT WAS REPORTED THAT THE PATIENT UNDERWENT REPLACEMENT OF L4 VERTEBRAL BODY DUE TO PSEUDOARTHROSIS OCCURRED AFTER THE VERTEBRAL BODY FRACTURE AT L4. OSTEOTOMY ON THE CONTRALATERAL SIDE WAS NOT DONE ENOUGH DURING CAGE PLACEMENT, SO CAGE PLACEMENT WAS PERFORMED NEAR THE APPROACHING SIDE. ALTHOUGH THE SURGEON ALSO ACKNOWLEDGED THAT THE OSTEOTOMY WAS NOT DONE ENOUGH, THE OPERATION WAS COMPLETED AS IT WAS. POST-OP, ON (B)(6) IT WAS FOUND BY CHECKING IMAGES DURING THE TWO STAGE SURGERY OF POSTERIOR FIXATION THAT 90% OF THE CAGE BACKED OUT. IT WAS PRESUMED THAT THE CAGE BACKED OUT DURING THE PERIOD FROM (B)(6) (AFTER THE OPERATION) TO (B)(6), AND THE ANTERIOR SIDE OF LUMBAR SPINE OPENED AND THE CAGE BACKED OUT WHEN THE PATIENT WAS IN SUPINE POSITION. IT WAS PLANNED TO PERFORM OSTEOTOMY ON THE CONTRALATERAL SIDE AGAIN AND TO PLACE THE CAGE FROM THE ANTERIOR SIDE ON (B)(6). DEVICE HAS BEEN REMOVED FROM THE PATIENT BODY IN THE REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9590066 ↗
• MalfunctionJan 2, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FIXATION, VERTEBRAL BODY REPLACEMENT AT L3 AND ANTERIOR FIXATION WAS PERFORMED AT L2-4 DUE TO COMPRESSION FRACTURE AT L3. IT WAS UNKNOWN HOW MUCH THE CAGE BACKED OUT. THE CAGE WAS PLACED IN THE STATE THAT THE ADJUSTING END CAPS WERE FREE ACCORDING TO THE SURGICAL TECHNIQUE, AND THE CAGE WAS LENGTHENED. IT WAS SAID THE CAGE DID NOT REACH THE VERTEBRAL BODY END PLATE DURING LENGTHENING, AND MAYBE THE SET SCREW ON THE SIDE OF THE ADJUSTING END CAPS SIDE WAS NOT LOOSENED ENOUGH, SO THE SET SCREW WAS LOOSENED AFTER REMOVAL, AND INSERTION WAS PERFORMED AGAIN, AND AT THAT TIME THE CAGE WAS LENGTHENED SUCCESSFULLY. AFTER PLACEMENT, IT WAS CHECKED WHETHER THE CAGE MOVES USING A SPATULA OF THE FACILITY, AND THERE WAS NO PROBLEM. POST-OPERATIVELY, THE CAGE PLACED BACKED OUT TOWARDS THE APPROACHED SIDE. BY CHECKING THE POST-OPERATIVE X-RAY IMAGE, IT SEEMED THAT THE UPPER END PLATE SIDE HAD NOT FIT SLIGHTLY. THE PATIENT HAD PAIN IN THE THIGH.

  Patient problems: Pain

  MAUDE report 9537454 ↗
• MalfunctionDec 26, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT DEMOGRAPHICS: GENDER-FEMALE, PRE-OPERATIVE DIAGNOSIS: TRAUMA, PROCEDURE: ANTERIOR FIXATION LEVELS, IMPLANTED: L2 DEVICE, STATUS: IMPLANTED-REMAINS IN SERVICE. IMPLANT DATE: (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FIXATION DUE TO TRAUMA. POST-OPERATIVELY, THE SELF-ADJUSTING END CAP MOVED AND THE CAGE MIGRATED. AFTER POSTERIOR FIXATION WAS PERFORMED, THE ALLEGED CAGE WAS PLACED THE NEXT WEEK. THE SELF-ADJUSTING END CAP WAS INSERTED IN A FREE STATE AND THE FINAL TIGHTENING WAS PERFORMED FOLLOWING THE SURGICAL TECHNIQUE. AT A LATER DATE, IT WAS POINTED OUT THAT THE CAGE HAS MIGRATED TO THE APPROACHING SIDE AND THE ANGLE OF THE SELF-ADJUSTING END CAP HAS CHANGED AS WELL. THE EXTENDED END CAP OF 45MM WAS USED. THERE WERE NO PATIENT COMPLICATION OCCUR AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519163 ↗