CD HORIZON® SOLERA® Spinal System 6534530Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 20643169885831), received between Oct 30, 2018 and May 20, 2025 — classified as 19 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT IN A PATIENT DIAGNOSED WITH ADULT SPINAL DEFORMITY. L3/4/5 DEGENERATIVE DISEASE OPERATION FIRST, FOLLOWED BY L1/2/3 XLIF AND FIXATION TO T11.12. IT WAS REPORTED THAT THE SET SCREW HAD BACKED OFF AND CURRENTLY REMAINS IN PATIENT. THE SET SCREW CAME OFF AFTER PROCEDURE. THERE IS NO ABNORMALITY FOR THE SCREWS. REOPERATION SCHEDULED FOR (B)(6) 2025. 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 22051238 ↗
• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT IN A PATIENT DIAGNOSED WITH ADULT SPINAL DEFORMITY. L3/4/5 DEGENERATIVE DISEASE OPERATION FIRST, FOLLOWED BY L1/2/3 XLIF AND FIXATION TO T11.12. IT WAS REPORTED THAT THE SET SCREW HAD BACKED OFF AND CURRENTLY REMAINS IN PATIENT. THE SET SCREW CAME OFF AFTER PROCEDURE. THERE IS NO ABNORMALITY FOR THE SCREWS. REOPERATION SCHEDULED FOR (B)(6) 2025. 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 22051151 ↗
• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT IN A PATIENT DIAGNOSED WITH ADULT SPINAL DEFORMITY. L3/4/5 DEGENERATIVE DISEASE OPERATION FIRST, FOLLOWED BY L1/2/3 XLIF AND FIXATION TO T11.12. IT WAS REPORTED THAT THE SET SCREW HAD BACKED OFF AND CURRENTLY REMAINS IN PATIENT. THE SET SCREW CAME OFF AFTER PROCEDURE. THERE IS NO ABNORMALITY FOR THE SCREWS. REOPERATION SCHEDULED FOR (B)(6) 2025. 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 22051131 ↗
• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT IN A PATIENT DIAGNOSED WITH ADULT SPINAL DEFORMITY. L3/4/5 DEGENERATIVE DISEASE OPERATION FIRST, FOLLOWED BY L1/2/3 XLIF AND FIXATION TO T11.12. IT WAS REPORTED THAT THE SET SCREW HAD BACKED OFF AND CURRENTLY REMAINS IN PATIENT. THE SET SCREW CAME OFF AFTER PROCEDURE. THERE IS NO ABNORMALITY FOR THE SCREWS. REOPERATION SCHEDULED FOR (B)(6) 2025. 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 22051118 ↗
• InjuryJun 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DISC HERNIATION OR LUMBAR INTERVERTEBRAL STENOSIS. IT WAS REPORTED THAT THE V5 SET SCREW DISLODGED AFTER SURGERY AND REINSTALLATION OCCURRED. THE CAGE COULD NOT BE REMOVED AT THE TIME OF REPEAT SURGERY, SO IT WAS PLACED STILL CONTRACTED (WHILE CONTINUED TO BE USED). THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE CAGE CONTRACTION, SO THERE ARE NO PLANS TO REMOVE IT AT THAT POINT. 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 19537666 ↗
• MalfunctionAug 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE PLIF PROCEDURE FOR STENOSIS. IT WAS REPORTED THAT SCREW DISLODGED AFTER SURGERY. AFTER THE L3/5 FIXATION, L2/5 EXTENSION WAS PERFORMED ON THE PATIENT. ALL SCREWS WERE REPLACED. NOTICED THAT THE SET SCREW OF L4 WAS DISLODGED ON THE X-RAY TAKEN ON THE 4TH DAY AFTER THE SURGERY. IMPLANT REMAINS IN PATIENT. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. NO REVISION SURGERY PLANNED TO EXPLANT FRAGMENT/DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538955 ↗
• MalfunctionNov 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR TH12 FRACTURE. LEVEL AT WHICH THE IMPLANT WAS PERFORMED: TH10 TO L2. MALFUNCTION OCCURRED IN THE VERTEBRAL BODY, ON THE RIGHT TH12. IT WAS REPORTED THAT ANOTHER COMPANY FIXATED AN IMPLANT ON TH9,10,11,12 ON THE POSTERIOR SPINAL FUSION SITE IN THE PREVIOUS SURGERY. THIS TIME, ALL OF THE PREVIOUS IMPLANTS WERE REMOVED AND THE PATIENT WAS FIXATED WITH THE VOYAGER 55/60; THE FUSION VERTEBRAL BODIES WERE TH10, 11, 12, L1, AND L2. A ROD 6.0 MM COBALT CHROME WAS USED. WHEN PLACING THE RIGHT ROD, THERE IS A GAP BETWEEN THE TH12 SCREW HEAD AND THE ROD, SO IT WAS SELECTED TO PUSH IT IN AND TIGHTEN IT WITH THE SET SCREW. HOWEVER, THE SET SCREW BROKE BEFORE THE ROD WAS COMPLETELY INSERTED INTO THE SCREW HEAD. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THE SET SCREW AND ROD WERE REMOVED, AND THE TH12 RIGHT SCREW WAS SLIGHTLY PULLED BACK (REMOVAL, ADJUSTING THE HEIGHT OF THE ROD'S BENDING), SO IT WAS TIGHTENED WITH A NEW SET SCREW. THE SECOND TIME, THERE WERE NO PROBLEMS AND THE FINAL TIGHTENING WAS SUCCESSFUL. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867573 ↗
• InjuryMay 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT REVISION SURGERY FOR 2A2B FIXATION DUE TO UPPER SCREW LOOSENED AND BACKED OUT. IT WAS REPORTED THAT THE SCREW BACKED OUT THAT CAUSED PAIN. REVISION SURGERY WAS SCHEDULED FOR REMOVAL OF SCREW AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REVISION SURGERY WAS PERFORMED AND PRODUCT WAS EXPLANTED ON (B)(6) 2022. THE OPERATION ON (B)(6) 2022 WAS FOR L2 RUPTURE FRACTURE AND L1/2 DECOMPRESSION. THERE WAS AN INFECTION IN THE DECOMPRESSED AREA AND WAS SUBSIDED BY WASHING AND ANTIBIOTICS. THE LOOSENING IS DUE TO THE PATIENT'S BONE FRAGILITY, SO THE DOCTOR DECIDED TO REMOVE ALL IMPLANTED PRODUCTS. BECAUSE, EVEN IF FIXING AND EXTENDING ARE PERFORMED, IT WILL BECOME LOOSE AGAIN, OR THE RISK OF LEADING UP TO ADJACENT VERTEBRAL BODY FRACTURE WILL BECOME HIGHER.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 14422920 ↗
• InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW, SET SCREWS, AND ROD IN AN L1 TO ILIAC + PLIF OF L5/S FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THIS IS A REPEAT SURGERY BECAUSE OF THE PULLING OFF OF THE SET SCREWS. DURING THE POSTOPERATIVE OBSERVATION, BOTH SIDES OF THE SET SCREWS CAME OFF. THERE WAS NO PRODUCT MALFUNCTION WITH THE SCREW AND ROD. NO SPECIFIC CAUSE HAS BEEN REPORTED AGAINST THE UNKNOWN SCREW. CLYDESDALE PTC WAS USED IN THE INITIAL SURGERY WHICH WAS AN L1 TO L5/4 INTERVERTEBRAL OLIF PERFORMED FOR THE POSTERIOR SIDE (SURGERY #2). SURGERY #1 WAS PERFORMED FOR THE ANTERIOR SIDE ON (B)(6) 2022 AT L1~L5. THESE TWO SURGERIES WERE THE INITIAL SURGERY. THE DOCTOR HAD PLANNED TO DIVIDE THE INITIAL SURGERY TWO TIMES AND THESE WERE PERFORMED AS SCHEDULED AND SUCCEEDED. PULLING OFF OF THE SET SCREWS WAS DISCOVERED DURING THE POST-OPERATIVE HOSPITALIZATION FOLLOW-UP OF SURGERY #2, SO THE PATIENT'S HOSPITALIZATION PERIOD WAS EXTENDED FOR THE CURRENT OPERATION. ADDITIONAL SURGERY WAS PERFORMED WHERE THE ILIAC SCREWS WERE REPLACED FOR FIXATION AND THE ENTIRE STRUCTURE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238818 ↗
• InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW, SET SCREWS, AND ROD IN AN L1 TO ILIAC + PLIF OF L5/S FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THIS IS A REPEAT SURGERY BECAUSE OF THE PULLING OFF OF THE SET SCREWS. DURING THE POSTOPERATIVE OBSERVATION, BOTH SIDES OF THE SET SCREWS CAME OFF. THERE WAS NO PRODUCT MALFUNCTION WITH THE SCREW AND ROD. NO SPECIFIC CAUSE HAS BEEN REPORTED AGAINST THE UNKNOWN SCREW. CLYDESDALE PTC WAS USED IN THE INITIAL SURGERY WHICH WAS AN L1 TO L5/4 INTERVERTEBRAL OLIF PERFORMED FOR THE POSTERIOR SIDE (SURGERY #2). SURGERY #1 WAS PERFORMED FOR THE ANTERIOR SIDE ON (B)(6) 2022 AT L1~L5. THESE TWO SURGERIES WERE THE INITIAL SURGERY. THE DOCTOR HAD PLANNED TO DIVIDE THE INITIAL SURGERY TWO TIMES AND THESE WERE PERFORMED AS SCHEDULED AND SUCCEEDED. PULLING OFF OF THE SET SCREWS WAS DISCOVERED DURING THE POST-OPERATIVE HOSPITALIZATION FOLLOW-UP OF SURGERY #2, SO THE PATIENT'S HOSPITALIZATION PERIOD WAS EXTENDED FOR THE CURRENT OPERATION. ADDITIONAL SURGERY WAS PERFORMED WHERE THE ILIAC SCREWS WERE REPLACED FOR FIXATION AND THE ENTIRE STRUCTURE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238786 ↗
• InjuryFeb 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- L3/4/5 LUMBAR SPINAL CANAL STENOSIS INVOLVED IN THE OLIF (OBLIQUE LATERAL INTERBODY FUSION) AND VOYAGER5.5/6.0 PROCEDURE. LEVELS IMPLANTED- L3/4/5. IT WAS REPORTED THAT POST-OPERATIVELY, AFTER INSERTING THE SCREW AND ROD, REOPERATION WAS PERFORMED BECAUSE THE SCREW BECAME LOOSE, AND THE SET SCREW CAME OFF. AFTER THAT, THE LOOSENESS OF THE SET SCREW WAS CONFIRMED AGAIN, SO OPERATION WAS PERFORMED AGAIN ON THE REPORTED DAY. L3/4/5 OLIF AND POSTERIOR PPS FIXATION. RE-OPERATION WAS PERFORMED BECAUSE THE SCREW ON THE RIGHT SIDE OF L4 WAS LOOSE AND THE SET SCREW OF L5 CAME OFF. PATIENT WAS HOSPITALIZED PROLONG DUE TO RE-OPERATION. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2022-FEB-02, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO IMPACT ON THE PATIENT. ON 2022-FEB-07, RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER AND THE PRODUCT NUMBER ARE DIFFERENT FOR THE L4 SCREW AND THE L5 SET SCREW. THE PRODUCT USED AT THE TIME OF THE INITIAL OPERATION WAS ALSO VOYAGER 5.5 / 6.0, AND AFTER THE INITIAL SURGERY, THE SCREW ON THE RIGHTL4 WAS LOOSENED AND THE SET SCREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589983 ↗
• InjuryFeb 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- L3/4/5 LUMBAR SPINAL CANAL STENOSIS INVOLVED IN THE OLIF (OBLIQUE LATERAL INTERBODY FUSION) AND VOYAGER5.5/6.0 PROCEDURE. LEVELS IMPLANTED- L3/4/5. IT WAS REPORTED THAT POST-OPERATIVELY, AFTER INSERTING THE SCREW AND ROD, REOPERATION WAS PERFORMED BECAUSE THE SCREW BECAME LOOSE, AND THE SET SCREW CAME OFF. AFTER THAT, THE LOOSENESS OF THE SET SCREW WAS CONFIRMED AGAIN, SO OPERATION WAS PERFORMED AGAIN ON THE REPORTED DAY. L3/4/5 OLIF AND POSTERIOR PPS FIXATION. RE-OPERATION WAS PERFORMED BECAUSE THE SCREW ON THE RIGHT SIDE OF L4 WAS LOOSE AND THE SET SCREW OF L5 CAME OFF. PATIENT WAS HOSPITALIZED PROLONG DUE TO RE-OPERATION. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2022-FEB-02, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO IMPACT ON THE PATIENT. ON 2022-FEB-07, RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER AND THE PRODUCT NUMBER ARE DIFFERENT FOR THE L4 SCREW AND THE L5 SET SCREW. THE PRODUCT USED AT THE TIME OF THE INITIAL OPERATION WAS ALSO VOYAGER 5.5 / 6.0, AND AFTER THE INITIAL SURGERY, THE SCREW ON THE RIGHTL4 WAS LOOSENED AND THE SET SCREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589967 ↗
• MalfunctionFeb 18, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A LUMBAR INTERBODY FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH L4 SPONDYLOLISTHESIS. IT WAS REPORTED THAT L4 SET SCREWS IDLED AND THE FINAL TIGHTENING COULD NOT BE PERFORMED. AFTER THE EVENT OCCURRED, THE ROD REDUCER WAS USED AND THE INSTALLATION WAS SUCCEEDED. THE STEPS OF THE SUCCESS WERE THAT THE EXTENDER WAS HELD WITH THE ROD BEING DROPPED INTO, AND THEN THE SET SCREWS WERE INSERTED. THE REPORTED SCREWS WERE INSERTED INTO THE PATIENT'S BODY THROUGH THE EXTENDER ONCE. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556231 ↗
• InjuryFeb 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SET SCREW BACKOUT INVOLVED IN THE SPINE RE-FIXATION PROCEDURE. LEVELS IMPLANTED: L1-S2. IT WAS REPORTED THAT POST-OPERATIVELY, THE SET SCREW OF THE S2AI SCREW BACKED OUT. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. EVENT WAS REVISION SURGERY. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR OVER 60 MINUTES. INITIAL SURGERY DETAILS- SIMULTANEOUS ANTERIOR-POSTERIOR FUSION WAS PERFORMED IN THE OPERATION PERFORMED ON (B)(6) 2019, AND FIXATION WAS EXTENDED ON (B)(6) 2021. SET SCREW BACKOUT OCCURRED, SO REFIXATION WAS PERFORMED. ON (B)(6) 2022, RECEIVED ADDITIONAL INFORMATION THAT PATIENT SYMPTOMS ARE UNKNOWN. ON (B)(6) 2022, RECEIVED UPDATED INFORMATION THAT AFTER THE INITIAL SURGERY (B)(6) ( 2019), THE PATIENT SUFFERED AN ADJACENT SEGMENT DISEASE, LEADING TO RE-SURGERY. CLYDESDALE PTC / VOYAGER 4.75 WAS USED AT THE TIME OF THE INITIAL SURGERY, BUT VOYAGER 4.75 WAS REMOVED AND REPLACED WITH VOYAGER 5.5 / 6.0 AT THE TIME OF RE-SURGERY ON (B)(6) 2021. THERE WAS A FEELING OF CROSS-THREADING WHEN INSERTING THE SET SCREW OF THE RE-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13495730 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SET SCREW DURING SET SCREW REPLACEMENT/ CROSSLINK PLACEMENT AT L4/5/SAI FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE PATIENT HAS HAD 4 OPERATIONS IN TOTAL. THE DATES OF THE INITIAL AND SECOND OPERATION ARE UNKNOWN. L3/4/5 OLIF AND VOYAGER FUSION WAS PERFORMED. MDT PRODUCT WAS REMOVED AND REPLACED IN TLIF FOR L5/S. TLIF WAS PERFORMED AT L5/S DUE TO SET SCREW BACKOUT. BALLAST WAS USED AT SAI. FUSION PERFORMED AT L5/S AND SAI. DURING THE HOSPITALIZATION PERIOD OF THE PATIENT, 2 SET SCREWS BACKED OUT, SO A REOPERATION WAS PERFORMED. SET SCREW REPLACEMENT AND CROSSLINK PLACEMENT WERE PERFORMED. THE EVENT WAS ASSOCIATED WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REOPERATION OCCURRED DUE TO SET SCREW BACKOUT. THIS PROCEDURE WAS A REVISION SURGERY, THERE WAS NO DELAY IN OVERALL PROCEDURE TIME, THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY. THE DATE OF IMPLANT WAS (B)(6) 2021 AND THE DATE OF EXPLANT WAS (B)(6) 2021. THE PATIENT'S MEDICAL HISTORY INCLUDES CEREBRAL PALS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023785 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SET SCREW DURING SET SCREW REPLACEMENT/ CROSSLINK PLACEMENT AT L4/5/SAI FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE PATIENT HAS HAD 4 OPERATIONS IN TOTAL. THE DATES OF THE INITIAL AND SECOND OPERATION ARE UNKNOWN. L3/4/5 OLIF AND VOYAGER FUSION WAS PERFORMED. MDT PRODUCT WAS REMOVED AND REPLACED IN TLIF FOR L5/S. TLIF WAS PERFORMED AT L5/S DUE TO SET SCREW BACKOUT. BALLAST WAS USED AT SAI. FUSION PERFORMED AT L5/S AND SAI. DURING THE HOSPITALIZATION PERIOD OF THE PATIENT, 2 SET SCREWS BACKED OUT, SO A REOPERATION WAS PERFORMED. SET SCREW REPLACEMENT AND CROSSLINK PLACEMENT WERE PERFORMED. THE EVENT WAS ASSOCIATED WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REOPERATION OCCURRED DUE TO SET SCREW BACKOUT. THIS PROCEDURE WAS A REVISION SURGERY, THERE WAS NO DELAY IN OVERALL PROCEDURE TIME, THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY. THE DATE OF IMPLANT WAS (B)(6) 2021 AND THE DATE OF EXPLANT WAS (B)(6) 2021. THE PATIENT'S MEDICAL HISTORY INCLUDES CEREBRAL PALS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023777 ↗
• InjuryNov 16, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW BACKED OUT. THE L4 SCREW WAS ALSO A LITTLE LOOSE. AS THE BACK PAIN WORSENED, ADDITIONAL SURGERY PERFORMED TO REMOVE THE SCREWS AND REPLACE THEM. SINCE THERE WAS A POSSIBILITY THAT THE DORSAL SIDE OF THE LEFT CAGE (CAPSTONEPEEKPTC) THAT HAD BEEN PLACED WAS INTERFERING WITH THE NERVE ROOT, THE POSTERIOR DECOMPRESSION OF THE LEFT SIDE WAS ALSO PERFORMED ADDITIONALLY SINCE THE CAGE WAS SINKING. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE ALLEGATION OF SCREW IS LOOSENESS. THERE WAS NO DEFECT WITH THE ROD.

  Patient problems: Pain

  MAUDE report 12818086 ↗
• InjuryNov 10, 2021Break; Break

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12785258 ↗
• MalfunctionJul 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OLIF(OBLIQUE LATERAL INTERBODY FUSION) AT L3/4/5, TLIF(TRANSFORAMINAL LUMBAR INTERBODY FU SION) AT L5/S AND PPS(PERCUTANEOUS PEDICLE SCREW PLACEMENT) AT L3-S DUE TO SPINAL CANAL STENOSIS. INTRA-OP, THE SET SCREWS OF L3 AND S WHICH HAD BEEN APPLIED COMPRESSION WAS LOOSE AFTER THE FINAL TIGHTENING. THE SET SCREWS WERE NOT TIGHTENED AFTER THE FINAL TIGHTENING. THE SET SCREWS WERE TIGHTENED AGAIN WITH A T27 DRIVER AND THE PROCEDURE WAS FINISHED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231466 ↗
• MalfunctionJul 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OLIF(OBLIQUE LATERAL INTERBODY FUSION) AT L3/4/5, TLIF(TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT L5/S AND PPS(PERCUTANEOUS PEDICLE SCREW PLACEMENT) AT L3-S DUE TO SPINAL CANAL STENOSIS. INTRA-OP, THE SET SCREWS OF L3 AND S WHICH HAD BEEN APPLIED COMPRESSION WAS LOOSE AFTER THE FINAL TIGHTENING. THE SET SCREWS WERE NOT TIGHTENED AFTER THE FINAL TIGHTENING. THE SET SCREWS WERE TIGHTENED AGAIN WITH A T27 DRIVER AND THE PROCEDURE WAS FINISHED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231465 ↗
• MalfunctionApr 1, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: LEVEL STENOSIS AT SINGLE LEVEL PROCEDURE PERFORMED: TLIF AT SINGLE LEVEL V5+AI LEVELS IMPLANTED: L4/5 INTRA OP, TIP OF THE SCREW DEFORMED AND THE THREADS WERE DAMAGED DUE TO WHICH SCREW LOOSEN. AFTER FINAL TIGHTENING, L4 SCREW WAS NOT FIXED AND THE HEAD WAS UNSTABLE. MINI-OPEN WAS PERFORMED, THEN THE SET SCREW WAS REMOVED AND ANOTHER SET SCREW WAS CONTINUED TO BE INSERTED, AND FINAL TIGHTENING WAS DONE. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9909213 ↗
• InjuryFeb 25, 2020Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT POST-OP, THE SET SCREW ON THE RIGHT SIDE BACKED OUT, AND THE SET SCREW ON THE LEFT SIDE LOOSENED. AS TO THE LOOSENESS OF THE SET SCREW ON THE LEFT SIDE, IT WAS FOUND THAT THE SET SCREW HAD LOOSENED AT THE TIME OF CHECKING DURING THE OPERATION. HENCE ON (B)(6) 2020, REVISION SURGERY PERFORMED IN WHICH BOTH THE SET SCREWS WERE REMOVED AND WERE PLACED AGAIN. ON THE RIGHT SIDE, ROD BENDING WAS PERFORMED ADDITIONALLY BECAUSE THE ROD HAD BEEN UNSTABLE TO THE EXTENT THAT THE ROD WAS ON THE SAME LEVEL AS THE SCREW HEAD. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. IT WAS OBSERVED AFTER OPERATION THROUGH PRODUCT IMAGE THAT BOTH SCREWS WERE DEFORMED AND BURRED AT THE TIPS, RUBBED AT THE THREADS, AND SECOND SCREW HAD SCRATCHES AND DEPOSITS ON THE THREADS. BOTH HAD NO MAJOR SCRATCHES ON THE THREAD. PATIENT COMPLICATIONS ARE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748700 ↗
• InjuryFeb 25, 2020Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT POST-OP, THE SET SCREW ON THE RIGHT SIDE BACKED OUT, AND THE SET SCREW ON THE LEFT SIDE LOOSENED. AS TO THE LOOSENESS OF THE SET SCREW ON THE LEFT SIDE, IT WAS FOUND THAT THE SET SCREW HAD LOOSENED AT THE TIME OF CHECKING DURING THE OPERATION. HENCE ON (B)(6) 2020, REVISION SURGERY PERFORMED IN WHICH BOTH THE SET SCREWS WERE REMOVED AND WERE PLACED AGAIN. ON THE RIGHT SIDE, ROD BENDING WAS PERFORMED ADDITIONALLY BECAUSE THE ROD HAD BEEN UNSTABLE TO THE EXTENT THAT THE ROD WAS ON THE SAME LEVEL AS THE SCREW HEAD. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. IT WAS OBSERVED AFTER OPERATION THROUGH PRODUCT IMAGE THAT BOTH SCREWS WERE DEFORMED AND BURRED AT THE TIPS, RUBBED AT THE THREADS, AND SECOND SCREW HAD SCRATCHES AND DEPOSITS ON THE THREADS. BOTH HAD NO MAJOR SCRATCHES ON THE THREAD. PATIENT COMPLICATIONS ARE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748696 ↗
• MalfunctionNov 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FIXATION AT L1-L3 DUE TO L2 CHANCE FRACTURE. INTRA OP, THE SET SCREW COULD NOT BE INSERTED AND ITS THREADS GOT DAMAGED ON INSERTION AT LEFT SIDE OF L3. THE SET SCREW WAS THEN EXPLANTED. IT IS SAID THAT THE SCREW AT THAT LOCATION WAS ANGLED COMPARED TO THE OTHER SCREWS. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272721 ↗
• MalfunctionNov 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FIXATION AT L1-L3 DUE TO L2 CHANCE FRACTURE. INTRA OP, THE SET SCREW COULD NOT BE INSERTED AND ITS THREADS GOT DAMAGED ON INSERTION AT LEFT SIDE OF L3. THE SET SCREW WAS THEN EXPLANTED. IT IS SAID THAT THE SCREW AT THAT LOCATION WAS ANGLED COMPARED TO THE OTHER SCREWS. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272703 ↗