Capstone Control PTC Spinal SystemRecalls & reported problems across all models

We found 12 models of Capstone Control PTC Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jun 24, 2018 and Jun 30, 2026 — classified as 13 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Capstone Control PTC Spinal System problems

Capstone Control PTC Spinal System models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Capstone Control PTC Spinal System 5011022

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• Capstone Control PTC Spinal System 5011222

  Intervertebral fusion device with bone graft, lumbar
  7 reports
• Capstone Control PTC Spinal System 5001122

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• Capstone Control PTC Spinal System 5011122

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• Capstone Control PTC Spinal System 5021322

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• Capstone Control PTC Spinal System 5001222

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• Capstone Control PTC Spinal System 5011227

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Capstone Control PTC Spinal System 5011327

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Capstone Control PTC Spinal System 5021527

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Capstone Control PTC Spinal System 5021522

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Capstone Control PTC Spinal System 5001022

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Capstone Control PTC Spinal System 5001027

  Intervertebral fusion device with bone graft, lumbar
  1 report

Recent Capstone Control PTC Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICALID: (B)(6) AND STUDY NAME AILLIANCE (B)(6). IT WAS REPORTED THAT THE PATIENT HAD LOWER INSTRUMENTED BODY FRACTURE (CORONAL SPLIT FRACTURE) L5 AND CONFIRMED WITH CT ON (B)(6) 2024 AND MRI ON (B)(6) 2024. DIAGNOSTIC TEST: X-RAY. DIAGNOSTIC TEST DATE: (B)(6) 2024. THE AE RESULT IN THE PROLONGATION OF AN EXISTING HOSPITALIZATION. START DATE OF THE HOSPITALIZATION: (B)(6) 2024. END DATE OF THE HOS PITALIZATION: (B)(6) 2024. INVESTIGATOR ASSESSMENT: THE ADVERSE EVENT WAS CONSIDERED PROBABLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE MEDTRONIC CST DEVICE. SPONSOR ASSESSMENT: THE ADVERSE EVENT WAS CONSIDERED AS CAUSALLY RELATED TO THE STUDY PROCEDURE AND TO THE MEDTRONIC CST DEVICE. OUTCOME OF THIS AE: RECOVERED/RESOLVED AS OF (B)(6) 2024.

  Patient problems: Bone Fracture(s)

  MAUDE report 25662667 ↗
• MalfunctionJan 5, 2026No Apparent Adverse Event; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS AN EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956498 ↗
• MalfunctionJan 5, 2026No Apparent Adverse Event; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS A EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956417 ↗
• MalfunctionAug 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE LEFT CAGE WAS POSITIONED TOO INWARD, SO IT WAS DECIDED TO REMOVE AND REPOSITION THE CAGE. THE CAGE WAS SUCCESSFULLY REMOVED WITHOUT ANY ISSUES USING THE INSERTER, BUT UPON INSPECTION OF THE REMOVED CAGE, THE MARKER WAS FOUND TO BE PROTRUDING. 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 22888980 ↗
• MalfunctionApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR L UMBAR INTERBODY FUSION. FOR LOWER SEGMENT CESAREAN SECTION (LSCS). IT WAS REPORTED THAT ALTHOUGH THERE WERE NO PROBLEMS WITH THE CAPSTONE CONTROL PTC 6° 12×22 PLACED ON THE RIGHT SIDE OF L3/4 IMMEDIATELY AFTER INSTALLATION, A BONE TRANSPLANT WAS PLACED ON THE MIDL INE AND A CAGE OF THE SAME SIZE WAS PLACED ON THE LEFT SIDE. AFTER THAT, THE CAGE WAS DROPPED NEAR THE OUTER PSOAS. THE PHYSICIAN DETERMINED THAT REMOVAL FROM THE BACK WAS DIFFICULT, AND THAT THERE WAS NO ADVERSE EFFECT ON TISSUE SUCH AS BLOOD VESSELS, SO THE CAGE WAS LEFT AS IS. ON THE RIGHT SIDE OF L3/4, CAPSTONE PTC 12×22 WAS PLACED AND THE PROCEDURE PROCEEDED TO SCREW INSERTION. THERE WAS DELAY OF LESS THAN 60 MINS. 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 21855057 ↗
• MalfunctionMar 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION FOR LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT DURING ROTATION,A MISALIGNMENT BETWEEN THE MARKER AND INSERTER WAS OBSERVED. AFTER REMOVAL, DEFORMATION OF THE CAGE WAS CONFIRMED. NO PATIENT SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662039 ↗
• MalfunctionDec 31, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 4/5 PLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR HERNIA. IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH THE SPECIFIED ITEM TO THE INSERTER, THE SCREW THREADS DID NOT MATCH AND IT COULD NOT BE ATTACHED. THE THREADS WHERE NOT EXPANDED, BUT RATHER THEY WERE SMALLER THAN USUAL. THERE IS NO VISIBLE DAMAGE TO THE THREADS, BUT CAN VISUALLY SEE SOMETHING LIKE A PEEK BURR. THE INSERTER IS NOT INCLUDED IN THE COMPLAINT AS IT HAD NO MALFUNCTION. 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 21046786 ↗
• MalfunctionJul 12, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT TRANSFOR AMINAL LUMBAR INTERBODY FUSION (TLIF) FOR POSTERIOR SPINAL FUSION DUE TO ADULT SPINAL DEFORMITY AND LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE DISTRACTOR WAS USED TO DISSECT UP TO 10 MM AND A THING OF THE SAME HEIGHT AS THE IMPLANT WAS USED IN THE TRIAL. FOR LEFT-SIDED PENETRATION, A 10 MM DISTRACTOR WAS VERTICALLY INSERTED AT THE RIGHT SIDE. THERE WAS RESISTANCE WHEN IT WAS ROTATED 90° IN THE INTERVERTEBRAL DISK, IT WAS ROTATED ON THE RIGHT SIDE USING THE LAMINA SPREADER. AFTER IT WAS ROTATED, THE SURGEON VISUALLY CONFIRMED THE DISTORTION OF THE CAGE. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983941 ↗
• InjuryFeb 14, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED ¿ COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522679 ↗
• InjuryFeb 14, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522621 ↗
• InjuryJul 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS; AND UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED CAGE BACKED-OUT BETWEEN L4 AND L5. ADDITIONALLY, A TOTAL OF 5 SCREWS LOOSENED AT THE FOLLOWING LOCATIONS: L5 LEFT, L5 RIGHT, L2 LEFT, L2 RIGHT AND L4 LEFT. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH ALL THE 5 LOOSENED SCREWS WERE REPLACED WITH NEW ONES AND THE BACKED-OUT CAGE WAS REPLACED WITH AUTOGENOUS BONE GRAFT. IN ADDITION, FIXATION WAS PERFORMED AT S1 AND S2AI WITH SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230716 ↗
• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION OF 3 INTRAVERTEBRAL DISCS (L3-S1). INTRA-OP, AFTER INSERTING THE CAGE AT L4-L5, THERE WAS A SENSE OF INCONGRUITY WHEN ROTATING THE CAGE. WHEN THE CAGE WAS REMOVED, IT WAS FOUND THAT THE CAGE HAD BEEN TWISTED AND DEFORMED. ALSO, THE INSERTER'S TIP WAS FOUND TO BE WIDENED, THE SURGEON PLACED IT BACK WITH PLIERS AND THE INSERTER WAS CONTINUED TO BE USED. THE DEFORMED CAGE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10032778 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP, PATIENT GOT INFECTED AND AS A RESULT OF THIS UNDERWENT REVISION SURGERY IN WHICH IMPLANTED CAGE AND SCREW WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9697548 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF LOWER BACK PAIN. IT WAS CONFIRMED BY THE MRI IMAGE THAT BRIGHTNESS CHANGED AT UPPER L5 LEVEL; AND IT WAS SUSPECTED THAT THE PATIENT HAD INFECTION AS HE HAD A CRP VALUE OF 6.8. L4-L5 INTERVERTEBRAL INFECTION WAS SUSPECTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE TWO CAGES AT L4-L5 LEVEL WERE REMOVED; AND ILIAC BONE GRAFTING WAS PERFORMED FROM THE ANTERIOR SIDE. ACCORDING TO THE HEALTHCARE PROFESSIONAL, IT CANNOT BE DETERMINED WHETHER THE INFECTION WAS CAUSED BY THE CAGES OR NOT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9548440 ↗
• MalfunctionNov 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S1 DUE TO LUMBAR CANAL STENOSIS. INTRA-OP, WHEN THE INSERTER WHICH WAS ATTACHED TO THE CAGE WAS INSERTED INTO THE INTERVERTEBRAL SPACE WITH A HAMMER (BEFORE ROTATING), IT WAS FOUND THAT THE SCREW OF THE INSERTER HAD LOOSENED. THE SCREW WAS TURNED AGAIN, BUT THE CAGE COULD NOT BE FIXED ONTO THE INSERTER AT ALL. THERE WERE DAMAGES AND DEFORMATION FOUND POST-OPERATIVELY ON THE CAGE THAT MUST HAD BEEN GENERATED DURING THE REMOVAL. SO THE CAGE WAS ONCE REMOVED AND ANOTHER CAGE WAS ATTACHED TO THE INSERTER. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND IT SEEMS HAMMERING WAS MORE THAN USUAL. AS REPORTED IN THE OVERALL PROCEDURE WAS DELAYED BY LESS THAN 60 MINS. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9325787 ↗

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