CLYDESDALE PTC™ Spinal System 4986845Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169190535), received between Jul 26, 2018 and Jul 15, 2022 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF APPROACH FOR LUMBAR SPINAL STENOSIS. LEVELS IMPLANTED : L3/4 IT WAS REPORTED THAT DURING INSERTION IN THE NARROW INTERVERTEBRAL, THE CAGE GRIPPING PART ON THE CAGE ENTRY SIDE WAS BROKEN. BROKEN CAGE GRIPPING PART REMAINED AROUND 4/5 CAGE. THE DEVICE WAS EXPLANTED PARTIALLY. THERE WAS A DELAY IN THE SURGERY BY LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FRAGMENT, A FOUR-FIFTHS PIECE, STILL REMAINS IN THE PATIENT'S BODY BUT THERE IS NO PLAN TO BE EXPLANTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15024740 ↗
• MalfunctionMay 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL STENOSIS; AND UNDERWENT ANTERIOR INTERBODY FUSION AND OBLIQUE LUMBAR INTERBODY FUSION AT L3-L5. INTRA-OP, THE CAGE BROKE WHILE ITS POSITION WAS BEING ADJUSTED. WHEN CHECKING THE IMAGE AFTER CAGE PLACEMENT, IT WAS FOUND THAT THE CAGE HAD ADVANCED TOO MUCH (FROM THE POSITION EXPECTED BY THE SURGEON) TO THE CONTRALATERAL SIDE. THEREFORE, THE POSITION OF THE CAGE WAS BEING ADJUSTED BY HAMMERING THE INSERTER HANDLE UPWARD FROM THE BOTTOM WHILE THE CAGE WAS GRIPPED BY THE INSERTER. ALTHOUGH THE CAGE POSITION COULD BE ADJUSTED, IT WAS NOTICED WHEN THE INSERTER WAS REMOVED THAT ABOUT 5MM OF THE CAGE WAS BROKEN. THE CAGE WAS BROKEN IN THE WAY THAT THE GRIPPING PART OF THE CAGE WAS STILL HELD BY THE INSERTER. THE REMAINING PORTION OF THE CAGE WAS PLACED IN A GOOD POSITION AND THERE WERE NOT MANY BROKEN PARTS; SO, THE CAGE WAS LEFT IMPLANTED INSIDE THE PATIENT¿S BODY ACCORDING TO THE JUDGEMENT OF THE SURGEON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS SAID THAT THE CAGE BREAKAGE WAS DUE TO HAMMERING THE INSERTER IN THE UPWARD DIRECTION. IT WAS CONSIDERED THAT THE INSERTER SWAYED TO THE CRANIAL AND CAUDAL SIDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10027755 ↗
• InjuryJun 27, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR KYPHOSCOLIOSIS; AND UNDERWENT LUMBAR ANTERIOR FIXATION AND OBLIQUE LUMBAR INTERBODY FUSION AT L1-L5. THE CAGES WERE BEING PLACED FROM THE LOWER VERTEBRAE MOVING TOWARDS UPPER VERTEBRAE. INTRA-OP, WHEN INSERTING THE LAST CAGE AT L1-L2, THE ANTERIOR LONGITUDINAL LIGAMENT (ALL) GOT INJURED. WHILE ADJUSTING THE POSITION OF THE CAGE, WHEN THE PHYSICIAN CHECKED THE SAGITTAL IMAGE, THE CAGE WAS FOUND INSERTED AT THE ANTERIOR SIDE OF THE VERTEBRAL BODY. THE CAGE WAS REMOVED TEMPORARILY, AND THE 'ALL' WAS FOUND ALMOST CUT. THE PHYSICIAN WAS SUGGESTED TO PLACE A BIGGER CAGE BEHIND AND MAKE IT STABLE AS A RECOVERY; HOWEVER, CAGE PLACEMENT WAS GIVEN UP BECAUSE IT WAS FRIGHTENING FOR THE SURGEON AS HE THOUGHT THAT THE CAGE WOULD COME OUT FROM THE ANTERIOR SIDE. WITH THE PHYSICIAN¿S JUDGEMENT, THE L1-L2 VERTEBRA WAS SUTURED USING A METAL WIRE AND ULTRA BLADE SO AS NOT TO OPEN THE ANTERIOR SIDE, AND THE OPERATION WAS COMPLETED WITHOUT INSERTING THE CAGE. OPERATION TIME WAS EXTENDED FOR ABOUT 90 MINUTES.

  Patient problems: Injury

  MAUDE report 8740838 ↗
• MalfunctionFeb 25, 2019Break; Break

  PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: ADULT SPINAL DEFORMITY PROCEDURE OR TECHNIQUE USED: OBLIQUE LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT INTRA-OP, THE PHYSICIAN INSERTED THE CAGE DIAGONALLY. WHILE A STRAIGHT INSERTER WAS INSERTED IN DIAGONALLY, THE CAGE TURNED JUST BESIDE AS IT ENTERED INTO THE VERTEBRAL BODY, AND WHEN APPLYING A CERTAIN AMOUNT OF FORCE, THE THREAD PART OF THE CAGE BROKE AND THE CAGE CAME OFF. THEN THE CAGE WAS ONCE REMOVED AND WAS REPLACED WITH ANOTHER ONE. THE NEW CAGE WAS INSERTED INTO THE PATIENT BODY SUCCESSFULLY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367932 ↗
• MalfunctionOct 30, 2018Break; Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018326 ↗
• MalfunctionJul 26, 2018Loose or Intermittent Connection

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS TYPE OF PROCEDURE: OBLIQUE LATERAL INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L4-L5 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, THE CAGE WAS ATTACHED TO THE SLEEVE INSERTER WITH TONGUE PART, THE PROTRUSION PART AT THE TIP WAS ENGAGED TO TIGHTEN THE SCREW, BUT ALTHOUGH THE CAGE SHOULD BECOME FIXED AFTER BEING TIGHTENED AS USUAL BUT IT DID NOT BECOME FIXED AND SEEMED TO IDLE, AND THE INSERTER COULD NOT HOLD THE CAGE. THERE WAS A DELAY IN OVERALL PROCEDURE OF LESS THAN 60 MIN AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7724403 ↗