CLYDESDALE PTC™ Spinal System 4986055Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169190719), received between Jan 5, 2018 and Mar 20, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 4, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4/5 OLIF: O NE-TIME PPS POSTERIOR FIXATION. IT WAS REPORTED THAT STARTING FROM OLIF, OARM NAVIGATION IS TURNED TO CHECK THE POINTER REPORT, APPROACHED THE SYSTEM WITHOUT ANY PROBLEMS, AND MOVED IT TO A GOOD POSITION WITH THE DEVELOPER DEVICE AND STARTED THE L3/ 4 AND THE OLIF. THERE WERE NO PROBLEMS WITH THE DISC, SO A TRIAL WAS INSERTED. THE SCREW ON THE HOLDER DID NOT ENGAGE. THE DIRECTION WAS CHECKED AGAIN AND TRIED, BUT IT DID NOT ENGAGE AT ALL. ONLY THE INNER CYLINDER OF THE HOLDER WAS TOOK OUT AND TRIED TO INSERT THE SCREW INTO THE SCREW HOLE OF THE CAGE, BUT IT WAS CONFIRMED THAT IT COULD NOT BE INSERTED AT ALL. AT THAT POINT, IT IMMEDIATELY GAVE UP ON THE CAGE AND A NEW PRODUCT OF THE SAME SIZE WAS PREPARED. WHEN THE BONE WAS REPLACED AND ATTACHED TO THE HOLDER, IT WAS FITTED WITHOUT ANY PROBLEMS. INSERTION WAS PERFORMED WITHOUT ANY PROBLEMS AND THE OLIF WAS COMPLETED. 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 19673822 ↗
• MalfunctionJul 26, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN L3/4/5 OBLIQUE LATERAL INTERBODY FUSION (OLIF) FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT DURING L4/5 OLIF CAGE IMPLANTATION, THE INSERTER CONNECTION WAS LOOSE, AND THE INSERTER WENT UP AND DOWN. IT COULD NOT BE RE-INSTALLED AS THE CONNECTION REGION WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE INSERTER DOES NOT HAVE ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396123 ↗
• MalfunctionSep 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SPINAL DEVICES USED IN L4/5 OBLIQUE LATERAL INTERBODY FUSION(OLIF). IT WAS REPORTED THAT THE CLAW TIP OF THE INSERTER WAS BROKEN, AND THE GRIPPING PART OF THE CAGE WAS BROKEN. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME LESS THAN 60 MINUTES. THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS L4/5/S LUMBAR CANAL STENOSIS (LCS). NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO OTHER SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402721 ↗
• InjuryNov 9, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LCS. IT WAS REPORTED THAT THE CAGE BACKED OUT. THE CAGE WAS EXPLANTED AND DISCARDED IN THE HOSPITAL. NO OTHER PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776658 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA OP DURING CAGE INSERTION, THE CAGE BROKE WHEN ABOUT 3/4 OF THE CAGE ENTERED THE INTERVERTEBRAL DISC SPACE. THE SURGEON TRIED TO RAISE THE CAGE BUT FAILED, AND THE CAGE BROKE WHEN THE SURGEON HAMMERED IT IN THAT STATE. IT WAS UNKNOWN IF THE INSERTION ANGLE WAS CORRECT BECAUSE THE IMAGE HAD BEEN SEEN FROM THE FRONT. BROKEN CAGE WAS REPLACED WITH ANOTHER ONE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9562272 ↗
• MalfunctionDec 25, 2019Crack; Crack

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) DUE TO UNKNOWN SURGERY. INTRA-OP, CAGE CRACKED WHILE INSERTING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517915 ↗
• InjuryFeb 25, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVEL IMPLANTED: L4/5 IT WAS REPORTED THAT INTRA-OP, THE CAGE WAS INSTALLED BY PERFORMING OLIF, BUT THE INSTALLING POSITION WAS SUNK INTO THE BONE AND IT WAS ATTEMPTED TO REMOVE THE CAGE. AT THAT TIME, THE THREAD PART OF THE CAGE BROKE, AND IT BECAME UNABLE TO REMOVE THE CAGE FROM THE PATIENT'S BODY BY USING INSERTER. ADDITIONALLY, SURGERY PERFORMED BECAUSE CAGE INSERTION BY OLIF APPROACHING FAILED SO POSTERIOR LUMBAR INTERBODY FUSION WITH POSTERIOR APPROACHING WAS PERFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367906 ↗
• InjuryJun 29, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE CAGE OF L4/5 DEVIATED LATERALLY. PATIENT UNDERWENT REVISION SURGERY FOR REPLACING THE IMPLANT. THE BACKED OUT CAGE WAS REMOVED FROM THE ANTERIOR SIDE, AND A CAGE OF AN INCREASED SIZE WAS NEWLY INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649988 ↗
• InjuryJan 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OLIF (OBLIQUE LUMBAR INTERBODY FUSION) AT L4-L5 DUE TO LCS (LUMBER CANAL STENOSIS). POST-OP, THE CAGE MOVED BACKWARDS SLIGHTLY. AS RESULT OF THIS, THE PATIENT SUFFERED MILD NUMBNESS AND UNDERWENT REVISION SURGERY FOR REMOVING THE DEFECTED CAGE.

  Patient problems: Numbness

  MAUDE report 7166992 ↗