CLYDESDALE PTC Spinal SystemRecalls & reported problems across all models

We found 28 models of CLYDESDALE PTC Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 167 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2016 and Sep 9, 2026 — classified as 37 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Break” (105 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 CLYDESDALE PTC Spinal System problems

CLYDESDALE PTC Spinal System models

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

• CLYDESDALE PTC™ Spinal System 4986050

  Intervertebral fusion device with bone graft, lumbar
  25 reports
• CLYDESDALE PTC™ Spinal System 4986850

  Intervertebral fusion device with bone graft, lumbar
  23 reports
• CLYDESDALE PTC™ Spinal System 4986855

  Intervertebral fusion device with bone graft, lumbar
  14 reports
• CLYDESDALE PTC™ Spinal System 4986045

  Intervertebral fusion device with bone graft, lumbar
  12 reports
• CLYDESDALE PTC™ Spinal System 4986055

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• CLYDESDALE PTC™ Spinal System 4922055

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• CLYDESDALE PTC™ Spinal System 4922050

  Intervertebral fusion device with bone graft, lumbar
  9 reports
• CLYDESDALE PTC™ Spinal System 4986250

  Intervertebral fusion device with bone graft, lumbar
  7 reports
• CLYDESDALE PTC™ Spinal System 4922045

  Intervertebral fusion device with bone graft, lumbar
  7 reports
• CLYDESDALE PTC™ Spinal System 4986845

  Intervertebral fusion device with bone graft, lumbar
  6 reports
• CLYDESDALE PTC™ Spinal System 4922250

  Intervertebral fusion device with bone graft, lumbar
  6 reports
• CLYDESDALE PTC™ Spinal System 4986840

  Intervertebral fusion device with bone graft, lumbar
  5 reports
• CLYDESDALE PTC™ Spinal System 4986255

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• CLYDESDALE PTC™ Spinal System 4926255

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• CLYDESDALE PTC™ Spinal System 4926250

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• CLYDESDALE PTC™ Spinal System 4986040

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CLYDESDALE PTC™ Spinal System 4922455

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CLYDESDALE PTC™ Spinal System 4986245

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CLYDESDALE PTC™ Spinal System 4926450

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CLYDESDALE PTC™ Spinal System 4922255

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CLYDESDALE PTC™ Spinal System 4922060

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CLYDESDALE PTC™ Spinal System 4986655

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4986240

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4926055

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4926045

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4922445

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4922260

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CLYDESDALE PTC™ Spinal System 4922245

  Intervertebral fusion device with bone graft, lumbar
  1 report

Recent CLYDESDALE 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.

• InjurySep 9, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Oblique Lumbar Interbody Fusion procedure at L2-5 for spinal canal stenosis. It was reported that the cage was damaged during insertion at L4/5, and it was determined that complete fragment removal would be difficult; hence, fragments reportedly remained in the patient. The treatment was changed to iliac bone grafting and rear fixation, and the procedure was delayed by more than 60 minutes. No further complications were reported in relation to the event. Additional information was received that a broken fragment of part of the damaged cage remained in the body. At the time of insertion, the intervertebral space was narrow and, at L4/5, the ilium was obstructing.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50688131 ↗
• MalfunctionJun 9, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT CAGE BROKE DURING INSERTION. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25440873 ↗
• MalfunctionMar 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR DEGENERATIVE KYPHOSCOLIOSIS. LEVEL AT WHICH THE IMPLANT WAS PERFORMED: L2-5 IT WAS REPORTED THAT THE CAGE WAS PLACED ON L4/5. WHEN THE SLEEVE WAS REMOVED WITH THE SLEEVE REMOVER, THE CAGE PROGRESSED TO THE CONTRALATERAL SIDE. ABOUT HALF OF THE CAGE WAS PROTRUDING FROM THE INTERVERTEBRAL DISC SPACE ON THE CONTRALATERAL SIDE. THE CAGE WAS PULLED BACK USING A REMOVER AND A SLAP HAMMER, AND IT WAS PLACED PROPERLY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650382 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH CAGE USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) FOR L3/4 SPONDYLOLISTHESIS SPINE. IT WAS REPORTED THAT THE OLIF CAGE WAS INST ALLED IN THE FRONT AND REAR OPPOSITE DIRECTIONS, WHICH WAS DIFFERENT FROM THE ORIGINAL PROPER USE, AFTER CHANGING THE POSITION FROM THE LATERAL POSITION TO THE PRONE POSITION. THE SURGEON DETERMINED THAT IT WAS VERY UNLIKELY THAT THE DEVICE WOULD AFFECT THE PATIENT, SO IT WAS PLACED IN THE BODY WITHOUT REINSERTION. THE CAUSE OF THE EVENT WAS CONFIRMED AS HUMAN ERROR. THERE WAS NO REVISION SURGERY OCCURRED/ PLANNED AS A RESULT OF THE EVENT. PRODUCT WAS NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640595 ↗
• MalfunctionMar 11, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571357 ↗
• MalfunctionMar 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE SCOLIOSIS. LEVELS IMPLANTED: L2/3 (SUCCESSFULLY INSTALLED), L3/4 (SUCCESSFULLY INSTALLED), L4/5 (SUCCESSFULLY INSTALLED AFTER ADDRESSING THE ISSUE) IT WAS REPORTED THAT THE SURGEON FELT STRANGE WHEN INSERTING THE OLIF CAGE, AND WHEN INTRAVITREAL INSERTION WAS STOPPED, THE INSERTER'S CAGE GRASP WAS LOOSE. THE SURGEON WAS ASKED TO RE-TIGHTEN THE CAGE, BUT STILL FELT IT WAS LOOSE, SO IT WAS REPLACED WITH A NEW ONE. IT SEEMS THAT NO PARTICULAR SLACK WAS FELT WHEN THE CAGE WAS ATTACHED TO THE INSERTER. WHEN THE CAGE WAS INSERTED. HAMMERING WAS PERFORMED AND INSERTION WAS ATTEMPTED; HOWEVER, IT WAS DIFFICULT TO GET INTO THE INTERVERTEBRAL SPACE, SO WHEN IT WAS CHECKED OUTSIDE THE SURGICAL FIELD, HE SAID THAT LOOSENING WAS FELT EVEN AFTER RE-TIGHTENING THE INSERTER. 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 21557549 ↗
• MalfunctionMar 2, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN LUMBAR LA TERAL FIXATION SURGERY. IT WAS REPORTED THAT WHILE ATTACHING THE CAGE TO THE INSERTER, IT COULD NOT BE ATTACHED DUE TO IDLING. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REPORTED CAGE WAS NOT BROKEN AND NOT USED ON THE PATIENT. THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500920 ↗
• InjuryFeb 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED FOR POSTERIOR FIXATION. LEVELS IMPLANTED WAS TH4-L5. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS SCOLIOSIS. IT WAS REPORTED THAT THE CAGE HAS COME LOOSE TO THE EXTENT THAT IT IS PIERCING INTO THE MUSCLE. PROCEDURE PERFORMED WAS REVISION SURGERY DUE TO DD DISLOCATION. MEDTRONIC PRODUCTS WERE NOT INVOLVED IN THE INITIAL SURGERY HAPPENED ON (B)(6) 2019. REOPERATION PLANNED AS A RESULT OF THE EVENT ON (B)(6), 2025 AND DURING THE REOPERATION WILL UNDERGO DD REMOVAL AND AUTOLOGOUS ILIUM TRANSPLANTATION. PATIENT SYMPTOMS ARE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CAGE WAS COMING OUT SO MUCH THAT IT WAS STUCK IN THE MUSCLES. PATIENT WAS NOT RECOVERED YET. THE POSTOPERATIVE CONDITION AFTER ADDITIONAL SURGERY WHICH HAPPENED ON 31(B)(6) 2025 WAS UNKNOWN. DURING THE ADDITIONAL SURGERY, DD WAS REMOVED, THE AUTOLOGOUS ILIAC BONE WAS TRANSPLANTED, AND THE OPERATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372683 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROFESSIONAL) REGARDING A CAGE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SIZE WAS DETERMINED DURING SURGERY AND AN ATTEMPT WAS MADE TO SET IT INTO THE IMPLANT HOLDER, BUT IT COULD NOT BE SET. LEVELS TO BE IMPLANTED WAS L1-2. THE SCREW THREAD OF THE CAGE WAS BROKEN, SO IT COULD NOT BE PLACED IN THE IMPLANT HOLDER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363964 ↗
• MalfunctionNov 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LATERAL LUMBAR INTERBODY FUSION THERAPY FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE CAGE BROKE WHILE INSERTING THE CAGE INTO THE BODY WHILE HITTING THE INSERTER WITH A HAMMER. ALL WERE REMOVED AND REPLACED WITH A NEW PRODUCT. IMPLANT WAS IMPLANTED AND EXPLANTED ON BOTH 10/9. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT IS HCV+, SO THE CUSTOMER REQUESTED DISPOSAL. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. 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 20599020 ↗
• MalfunctionOct 21, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT CAGE COULD NOT ATTACHED TO INSERTER. PATIENT SYMPTOMS WERE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490759 ↗
• MalfunctionOct 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-4, L4-5 LATE RAL INTERBODY FUSION FOR AN INDICATION OF DEGENERATIVE DISC DISEASE WITH SPONDOLOLYSTHESIS L3-5. IT WAS REPORTED THAT WHILE ATTEMPTING TO THREAD THE CAGE INTO THE INSERTER, IT WAS NOT LOADING PROPERLY AND WAS DEEMED NOT SUITABLE. THE IMPLANT WAS REPLACED WITH A NEW IMPLANT OF THE SAME SIZE TO COMPLETE THE PROCEDURE. 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 20437299 ↗
• MalfunctionOct 8, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF OBLIQUE LATERAL INTERBODY FUSION THERAPY FOR DECOMPRESSION SURGERY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED AT L4-5 IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED, THE CONNECTION BETWEEN THE NAVI INSERTER AND THE CAGE CAME OFF. AT THAT TIME, THE PART THAT WAS IN CONTACT WITH THE INSERTER WAS DAMAGED. IT BECAME DIFFICULT TO REMOVE THE DEVICE, SO IT WAS DECIDED TO PUSH THE CAGE AND THE INSTALLATION WAS COMPLETED, SO THE OLIF WAS COMPLETED. THERE WAS LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE EVENT HAPPENED DURING NORMAL USAGE OF DEVICE AND NOT A MANUFACTURING ISSUE. THERE IS NO ADDITIONAL SURGERY PLANNED OR SCHEDULED TO REMOVE THE IMPLANTED CAGE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION/ALLEGATION ASSOCIATED WITH THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397375 ↗
• MalfunctionOct 8, 2024Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT PATIENT UNDERGOING OLIF OBLIQUE-LATERAL LUMBAR INTERBODY FUSION THERAPY FOR ADULT SPINAL DEFORMITY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED AT T12-L5 IT WAS REPORTED THAT HERE WAS AN ERROR IN THE LEVEL L2/3 DURING THE OLIF IMPLEMENTATION PROCESS, SO A CAGE WAS INSTALLED IN L1/2 WHERE THE PROCEDURE HAD ALREADY BEEN PERFORMED, AND THE PREVIOUSLY INSTALLED CAGE DISLODGED TO CONTRALATERAL SIDE. THERE WAS LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE CAGE THAT WAS ORIGINALLY INSTALLED IN L1/2 WAS PUSHED TO THE OPPOSITE SIDE. A CAGE WAS INSTALLED IN L2/3 AND THE WOUND WAS CLOSED. THE CAGE THAT DEVIATED TO THE OPPOSITE SIDE WAS REMOVED BY THE RIGHT APPROACH. THERE WAS NO INITIAL DEFECT WITH THE PRODUCT . ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION OR ALLEGATION ASSOCIATED WITH O-ARM OR ANY NAVIGATION DEVICE. IT IS THOUGHT THE THE WRONG LEVEL INSTALLATION WAS DUE TO THE USER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397216 ↗
• MalfunctionAug 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE BROKE OFF NEAR INSERTER DURING INSERTION AND IT WAS PULLED OUT OF THE DISC SPACE SUCCESSFULLY. 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 19904411 ↗

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