CLYDESDALE PTC™ Spinal System 4986045Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169190733), received between Jan 13, 2017 and Mar 10, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO WOUND INFECTION. OPERATED IN 2022 AT MESA, SURGICAL SPINE, INC. IN 2022. SCOLIOSIS. AFTER THAT, RE-SURGERY WAS PERFORMED ON (B)(6) 2023. THERE WERE NO MEDTRONIC PRODUCTS USED IN THE INITIAL SURGERY. THE CAUSE OF THE INFECTION IS UNKNOWN. IT IS SAID THAT IT WAS INFECTED FROM THE VICINITY TO THE LOWER PART. THE HOSPITAL WAS VISITED ON THE SAME DAY WITH ONLY THE INFORMATION CAGE MIGHT BE REMOVED. THERE WAS NO INFECTION IN THE CAGE, BUT DURING THE OPERATION ON (B)(6) 2023, OLIF ON L1-2-3, REAR SCREW SKIPPED L2, SO THE DD BETWEEN THE L2-3 WAS REMOVED FROM THE LEFT. ALL REAR SCREWS ARE MESA. ROD WAS DISCONNECTED FROM THE RIGHT LOWER SCREW HEAD. HOSPITAL DISPOSED THE PRODUCT DUE TO INFECTION. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT DUE TO INFECTION, THE REMOVED DD WAS DISCARDED IN THE HOSPITAL. ONLY THE DD WAS MDT PRODUCT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18697264 ↗
• MalfunctionFeb 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- DEGENERATIVE SCOLIOSIS INVOLVED IN THE SACROILIAC JOINT AND THORACOLUMBAR SPINE (LOWER SPINE, MIDDLE SPINE). LEVELS IMPLANTED- L2/3. IT WAS REPORTED THAT DURING OPERATION, AFTER INSERTING THE CAGE TO THE L2/3 LEVEL, THE INSERTER WAS REATTACHED FOR ADDITIONAL INSERTION AND THE INSERTION WAS ATTEMPTED, BUT IT DID NOT MOVE, AND THE CAGE BROKE FROM THE ATTACHMENT PART WHEN HIT WITH A HAMMER. FRAGMENT REMAINS IN THE PATIENT BODY. BROKEN PARTS WERE COLLECTED AND DISCARDED (BLOOD CONTAMINATION). THE CAGE MAIN BODY WAS LEFT IN PATIENT¿S BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON 2022-FEB-07, RECEIVED ADDITIONAL INFORMATION THAT THERE IS NO PLAN FOR REVISION SURGERY TO EXPLANT THE BROKEN FRAGMENT FROM THE PATIENT'S BODY. FRAGMENT REMAINED AT THE IMPLANTED LEVEL- L2/3.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13617184 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR FIXATION AT L3-L4 DUE TO LUMBAR CANAL STENOSIS. GRAFT WAS PLACED INSIDE THE CAGE; AND THE CAGE WAS IMPLANTED AT THE TREATED INTERVERTEBRAL DISC SPACE. ON OR AROUND (B)(6) 2019, ABOUT TWO WEEKS POST-OP, THE PATIENT HAD A CRP RISE AND FEVER. INFECTION WAS ALSO FOUND AT THE FIXED PART BETWEEN THE VERTEBRAL BODIES. THE PATIENT HAS RECEIVED MEDICATION. HOSPITALIZATION WAS PROLONGED BUT THE PROLONGATION TIME WAS UNSPECIFIED. BONE UNION IS NOT COMPLETE YET (AFTER TWO AND A HALF MONTHS FROM OPERATION). THE SYMPTOMS ARE NOW REPORTED TO BE SETTLING DOWN AND THE PATIENT ISSUE IS GETTING RESOLVED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 8929263 ↗
• MalfunctionMay 24, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR ANTERO-POSTERIOR FIXATION AT L4-L5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, THE POSTERIOR SIDE OF THE CAGE CHIPPED WHEN ADJUSTING THE DIRECTION OF CAGE DURING INSERTION. THE CAGE WAS INSERTED AS IT WAS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE ALLEGED EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639528 ↗
• InjuryMar 25, 2019Migration; Migration

  PRE-OPERATIVE DIAGNOSIS: ADULT DEFORMITY PROCEDURE: OLIF(OBLIQUE LUMBAR INTERBODY FUSION) LEVELS IMPLANTED: L1/2 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE CAGE BACKED OUT. THE PATIENT DID NOT ACHIEVE SOLID FUSION. LOWER EXTREMITY PAIN OCCURRED TO THE PATIENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT. A REVISION SURGERY WAS SCHEDULED AND THE CAGE WAS REPLACED.

  Patient problems: Pain

  MAUDE report 8447556 ↗
• InjurySep 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN CONFIRMED THAT THE CAGE ADVANCED DEEPER WHEN IT WAS HAMMERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888262 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SCOLIOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION(OLIF) SURGERY AT L2-5 LEVELS. DURING SURGERY,THE CAGE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. FRAGMENTS OF THE CAGE REMAINS IN THE PATIENT. ABOUT 90% OF THE CAGE WAS EXPLANTED. 10% OF IT WAS NOT COLLECTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE 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 7796464 ↗
• MalfunctionDec 27, 2017Break; Break

  PRE-OP DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS OPERATED: L2/3, L3/4 IT WAS REPORTED THAT DURING SURGERY, THE GRASPING MECHANISM OF THE CAGE BROKE. IT WAS CONFIRMED THAT INSERTER COULD NO LONGER GRASP THE CAGE WHEN DETACHING THE CAGE FROM IT. NO NARROWING OF THE INTERVERTEBRAL DISC WAS OBSERVED, AND THE CAGE WAS SEEMED TO BE INSERTED PARALLEL AGAINST THE INTERVERTEBRAL DISC. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147186 ↗
• MalfunctionDec 22, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS AT L3/4, L4/5 AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, THE FRAGMENTS OF THE PEEK WAS ATTACHED ON THE INSERTER THREAD PART AFTER INSERTING THE CAGE. THE CAGE COULD NOT BE GRASPED AND WAS LOOSE SO THE INSERTER WAS CHECKED CAREFULLY. PATIENT COMPLICATIONS REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141501 ↗
• MalfunctionJan 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE SCOLIOSIS UNDERWENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION SURGERY AT L2/3/4/5 ON (B)(6) 2016 AND POSTERIOR LUMBAR INTERBODY FUSION AT L5/6 AND L6/S AS TWO-STAGE SURGERY ON (B)(6) 2016 .ON AN UNKNOWN DATE, POST-OP, THE CAGE INSERTED AT L4/5 IN OLIF SURGERY BACKED OUT TOWARDS THE PLACED SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6248752 ↗