CLYDESDALE PTC™ Spinal System 4922055Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169191075), received between Dec 23, 2016 and Aug 28, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionAug 28, 2023Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF25 3 VERTEB RAE (L2/3, L3/4, L4/5) FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE DISC HEIGHT WAS NARROW (4 - 5 MM), BUT THE DOCTOR WANTED TO INSERT A CAGE WITH A GREATER HEIGHT. AFTER THE TRIAL, THE INSERTION OF THE PRODUCT WAS TRIED, BUT IT CRACKED. FIRST, A CAGE WAS PLACED IN L4/5. NEXT, 2 CAGES BROKE DURING CAGE INSERTION IN L3/4, AND FINALLY A  CAGE WAS PLACED. THREE PIECES BROKE DURING CAGE INSERTION IN THE FINAL L2/3, AND FINALLY ANOTHER CAGE WAS PLACED. THE BROKEN CAGES AND BROKEN FRAGMENTS WERE SECURED, BUT IT IS UNKNOWN IF THE BROKEN FRAGMENTS WERE LEFT BEHIND IN THE BODY BECAUSE THEY COULD NOT BE FLUOROSCOPICALLY CHECKED. THERE WAS A DELAY IN THE PROCEDURE BY MORE THAN 60 MINUTES. 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 17629479 ↗
• MalfunctionFeb 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OLIF(OBLIQUE LUMBAR INTERBODY FUSION) SURGERY AT L1-L4 DUE TO THORACOLUMBAR KYPHOSCOLIOSISON. INTRA-OP, A PART OF THE CAGE'S POSTERIOR PART BROKE DURING CAGE INSERTION. ALTHOUGH THE INSERTER HAS NOT INTERFERED WITH THE RETRACTOR ITSELF, THERE HAD BEEN ANGLE AT THE TIME OF INSERTION DUE TO ILIAC OVERHANG. THE CAGE WAS CONTINUED TO BE IMPLANTED AND THE BROKEN PART WAS REMOVED, LEAVING NO BROKEN FRAGMENTS IN THE PATIENT BODY. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AND NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9731631 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-L5 OBLIQUE LUMBAR INTERBODY FUSION DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, THE CAGE BROKE. THE SURGEON INSERTED THE CAGE AND THEN REMOVED THE INSERTER. THEN, WHILE HAMMERING THE CAGE, A SMALL POSTERIOR PART OF THE CAGE BROKE-OFF. THE BROKEN PART OF THE CAGE WAS REMOVED FROM THE PATIENT'S BODY WHILE MOST OF THE CAGE REMAINED INSIDE THE PATIENT IN A NORMAL POSITION. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS OR NOT. THE SMALL PIECE OF THE CAGE THAT BROKE-OFF WAS DISCARDED IN THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9128139 ↗
• InjurySep 25, 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 (OLIF) AT L4-L5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, AT THE TIME OF PLACING THE RETRACTOR, BLEEDING WAS OBSERVED ON THE ENTRY SIDE. IT WAS CONSIDERED THAT THE BLEEDING WAS FROM THE MUSCLES; HENCE, HEMOSTASIS WAS PERFORMED AND THE BLEEDING STOPPED. THE SURGERY WAS THEN CONTINUED. WOUND CLOSURE WAS PERFORMED AND THE PATIENT LEFT THE OPERATION ROOM. POST-OP, BLEEDING TENDENCY WAS CONFIRMED. THE SURGEON SUSPECTED BLEEDING OCCURRED AT SOMATIC ARTERIES. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY; AND EMBOLIZATION WAS PERFORMED. NOW, THE PROGNOSIS IS GOOD AND PATIENT'S ISSUE HAS BEEN REPORTED TO HAVE RESOLVED. NO MALFUNCTION FOR THE REPORTED PRODUCT HAS BEEN REPORTED. ACCORDING TO THE SALES REP, THIS PRODUCT WAS REPORTED AS IT WAS A PART OF THE EVENT.

  Patient problems: Blood Loss; Injury

  MAUDE report 9114891 ↗
• MalfunctionSep 11, 2018Break; Break

  PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF CURVED END PLATE PROTECTOR) PRE-OPERATIVE DIAGNOSIS: LUMBAR CANAL STENOSIS(LCS) LEVEL IMPLANTED: L4/5 IT WAS REPORTED THAT INTRA-OP, THE ILIAC BONE BECAME AN OBSTACLE AND THE TRIAL COULD NOT ENTER. THE CAGE WAS CRUSHED DURING INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865844 ↗
• InjuryJul 17, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUS ION (OLIF) SURGERY AND WAS IMPLANTED AT L3/5 LEVELS. DURING SURGERY, WHEN THE ALLEGED CAGE WAS INSERTED OBLIQUELY ON L4/5 AND WAS HAMMERED A LITTLE TOO MUCH TO CONTRALATERAL SIDE, NERVE ROOT WAS COMPRESSED AND NERVE ROOT SYMPTOM WAS FOUND. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PRODUCT BREAKAGES WERE REPORTED. AS A RESULT OF THIS COMPLICATION, A REVISION SURGERY IS SCHEDULED ON (B)(6) 2018.

  Patient problems: Nerve Damage; No Code Available

  MAUDE report 7693166 ↗
• MalfunctionMar 21, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS ASSOCIATED WITH L3 BURST FRACTURE UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, AFTER COMPLETING THE CAGE INSERTION AT L3/4, WHEN THE INSERTER WAS DETACHED FROM THE CAGE, THE CONNECTING PART (POSTERIOR PART) OF THE CAGE WAS BROKEN AND WAS FOUND REMAINING IN THE INSERTER. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PART OF THE CAGE WAS IMPLANTED IN THE PATIENT AND THE REMAINING PART WAS DISCARDED BY THE FACILITY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7359024 ↗
• MalfunctionApr 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT WITH LUMBAR SPONDYLOLISTHESIS UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-5, DURING WHICH THE CAGE BROKE AT THE AREA ATTACHING IT TO HOLDER PART OF AN INSERTER DURING INSERTION AND IT WAS REMOVED. THE BROKEN CAGE WAS ENTIRELY REMOVED AND REPLACED WITH NEW ONE. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529139 ↗
• MalfunctionApr 25, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS DUE TO PARKINSON'S DISEASE PROCEDURE:OBLIQUE LATERAL INTERBODY FUSION (OLIF) IT WAS REPORTED THAT DURING SURGERY, THE SURGEON ATTACHED THE CAGE TO AN INSERTER AND TRIED TO INSERT IT BETWEEN L4/5 USING A PUNCH TYPE HAMMER. BUT LOAD WAS APPLIED TO THE SCREW PART WHILE GRASPING THE IMPLANT, THE SCREW PART OF THE IMPLANT GOT A CRACK, AND THE INSERTER WAS DISCONNECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517880 ↗
• MalfunctionDec 23, 2016Break; Break

  PRE-OP DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS INVOLVED: L3-5 IT WAS REPORTED THAT DURING SURGERY, AFTER INSERTING THE CAGE AT L4/5, THE SLEEVE WAS REMOVED COMPLETELY FROM INTER-BODY. THE HANDLE WAS SLAPPED BY THE HAMMER IN DIRECTION OF PULLING OUT, DUE TO WHICH THE CAGE BROKE. THE BROKEN PART DID NOT REMAIN IN THE PATIENT¿S BODY. THE FRAGMENTS WERE DISCARDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6201710 ↗