CLYDESDALE PTC™ Spinal System 4986250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169190672), received between Dec 28, 2016 and Apr 21, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE IMPLANT WAS ATTACHED CORRECTLY TO THE INSERTER, DURING IMPLANTATION A PIECE OF THE PEEK BROKE OFF AND THE SURGEON THEN TAMPED IN THE REST OF THE CAGE A SMALL PIECE WAS BROKEN OFF AND WAS LEFT OUT OF THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO SYMPTOMS WERE REPORTED. 2021-APR-20_E1 (REP):. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT LOT NUMBER IS 525985. THERE WAS NO REVISION SURGERY OR ADDITIONAL SURGERY. A LITTLE BIT OF DELAY MAYBE 5 MINUTES TO TAMP THE IMPLANT IN WITHOUT THE INSERTER. THE BROKEN PART WAS THROWN AWAY BY ACCIDENT. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT IS DOING WELL POST OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699451 ↗
• InjuryDec 20, 2018Adverse 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 (OLIF) AT L4/5 DUE TO LUMBAR SPINAL CANAL STENOSIS (LSCS). IN WHICH, A CAGE WAS IMPLANTED. POST-OP, DISC HERNIATION WAS NOTED AND LATERAL HERNIA WAS DETECTED (AFTER PERFORMING MRI) AT THE SAME PLACE WHERE THE CAGE WAS IMPLANTED. HENCE, A HERNIATION REMOVAL SURGERY (HERNIOTOMY) WAS PERFORMED. ALSO, THE PATIENT SUFFERS DUE TO NERVE ROOT DISORDER DUE TO THIS EVENT. THERE WAS NO ISSUE WITH THE CAGE; HENCE, THE CAGE WAS RE-IMPLANTED. THE PATIENT'S ISSUE IS NOW RESOLVED. THE PATIENT DISCHARGED FROM HOSPITAL.

  Patient problems: Hernia; Neuropathy

  MAUDE report 8183474 ↗
• MalfunctionAug 10, 2018Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTER-BODY FUSION(OLIF) AT L4/5 DUE TO LUMBAR SPINAL CANAL STENOSIS. DURING THE CAGE INSERTION, SHAVING (FRAGMENT) OCCURRED FROM THE SURROUNDINGS OF THE CAGE SCREW HOLE. SINCE IT WAS A TINY AMOUNT, THE OPERATION WAS CONTINUED AS NO PROBLEM. NOTHING REMAINED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7771500 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABDOMINAL DISTENSION, URETER INJURY IN PATIENT WAS OBSERVED ON (B)(6) 2018. IT COULD BE CONFIRMED A DUCT WAS ON THE INTER-VERTEBRAL DISC BY VISUAL WHEN DISSECTING THE INTER-VERTEBRAL DISC. THE RETRACTION WAS PERFORMED USING AN ELONGATED ROD SHAPED PRODUCT CALLED NERVE HOOK WHICH WAS OWNED BY THE HOSPITAL. THE INJURY POSITION OF URETER WAS NEAR L4/5.

  Patient problems: Injury; Swelling

  MAUDE report 7428018 ↗
• MalfunctionMar 3, 2017Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE LUMBAR PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L2-L3 IT WAS REPORTED THAT THE PART OF THE CAGE WAS BENT AND DEFORMED DURING SURGERY. DIRECTION OF THE CAGE AND THE INSERTER WERE REVERSED FOR L2-L3. THE TIP OF THE INSERTER WAS DEFORMED, WHICH LED THE CAGE DEFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6375596 ↗
• MalfunctionDec 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH KYPHOSIS UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. POST OP, CAGES AT L4-L5 DEVIATED. NO PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY IS PLANNED SO FAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6207978 ↗
• MalfunctionDec 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH KYPHOSIS UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. POST OP, CAGES AT L4-L5 DEVIATED. NO PATIENT CO MPLICATIONS WERE REPORTED. NO REVISION SURGERY IS PLANNED SO FAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6207976 ↗