CLYDESDALE PTC™ Spinal System 4922050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169190795), received between Aug 9, 2018 and Jul 24, 2023 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2/3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH HYPERTENSIVE DISEASE, PULMONARY EMBOLISM/BOTH LOWER LEG VENOUS FLOW/DEMENTIA, P SEUDOGOUT AND FRACTURE OF RIGHT UPPER CARPAL BONE. IT WAS REPORTED THAT THE OLIF WAS INITIATED IN THE ORDER OF L3/4 TO L2/3 TO L4/5. THE CAGES WERE PLACED SMOOTHLY FOR L3/4 AND L2/3 OLIF, BUT THE L4/5 CAGE WAS DIFFICULT TO APPROACH, AND THE CURVED INSERTER WAS USED TO APPROACH THE ILIAC OVERHANG. AT THAT TIME, THE TIP OF THE INSERTER BROKE, CAUSING A DEFECT WHERE THE CAGE WAS DETACHED FROM THE INSERTER. THE L4/5 INTERVERTEBRAL SPACE WAS TOO NARROW FOR TRIAL INSERTION. THREE ATTEMPTS WERE MADE TO PLACE THE L4/5 CAGE, BUT IT COULD NOT BE PLACED PROPERLY. THE BROKEN PARTS OF THE CAGE AND INSERTER WERE REMOVED, AND THE INSERTER AND CAGE WERE CHANGED AND INSERTION WAS DONE AGAIN, BUT THE CAGE GOT BROKEN AGAIN. A NEW CAGE WAS TAKEN OUT AND INSERTION WAS TRIED FOR THE THIRD TIME. HOWEVER, HALFWAY THROUGH THE INSERTION (WHEN THE CAGE WAS ABOUT HALFWAY INSERTED BETWEEN THE VERTEBRAE), THE INSERTER AND CAGE COULD NO LONGER BE GRASP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378903 ↗
• MalfunctionJul 24, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2/3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH HYPERTENSIVE DISEASE, PULMONARY EMBOLISM/BOTH LOWER LEG VENOUS FLOW/DEMENTIA, P SEUDOGOUT AND FRACTURE OF RIGHT UPPER CARPAL BONE. IT WAS REPORTED THAT THE OLIF WAS INITIATED IN THE ORDER OF L3/4 TO L2/3 TO L4/5. THE CAGES WERE PLACED SMOOTHLY FOR L3/4 AND L2/3 OLIF, BUT THE L4/5 CAGE WAS DIFFICULT TO APPROACH, AND THE CURVED INSERTER WAS USED TO APPROACH THE ILIAC OVERHANG. AT THAT TIME, THE TIP OF THE INSERTER BROKE, CAUSING A DEFECT WHERE THE CAGE WAS DETACHED FROM THE INSERTER. THE L4/5 INTERVERTEBRAL SPACE WAS TOO NARROW FOR TRIAL INSERTION. THREE ATTEMPTS WERE MADE TO PLACE THE L4/5 CAGE, BUT IT COULD NOT BE PLACED PROPERLY. THE BROKEN PARTS OF THE CAGE AND INSERTER WERE REMOVED, AND THE INSERTER AND CAGE WERE CHANGED AND INSERTION WAS DONE AGAIN, BUT THE CAGE GOT BROKEN AGAIN. A NEW CAGE WAS TAKEN OUT AND INSERTION WAS TRIED FOR THE THIRD TIME. HOWEVER, HALFWAY THROUGH THE INSERTION (WHEN THE CAGE WAS ABOUT HALFWAY INSERTED BETWEEN THE VERTEBRAE), THE INSERTER AND CAGE COULD NO LONGER BE GRASP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378896 ↗
• MalfunctionJan 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2/3/4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH HYPERTENSIVE DISEASE, PULMONARY EMBOLISM/BOTH LOWER LEG VENOUS FLOW/DEMENTIA, P SEUDOGOUT AND FRACTURE OF RIGHT UPPER CARPAL BONE. IT WAS REPORTED THAT THE OLIF WAS INITIATED IN THE ORDER OF L3/4 TO L2/3 TO L4/5. THE CAGES WERE PLACED SMOOTHLY FOR L3/4 AND L2/3 OLIF, BUT THE L4/5 CAGE WAS DIFFICULT TO APPROACH, AND THE CURVED INSERTER WAS USED TO APPROACH THE ILIAC OVERHANG. AT THAT TIME, THE TIP OF THE INSERTER BROKE, CAUSING A DEFECT WHERE THE CAGE WAS DETACHED FROM THE INSERTER. THE L4/5 INTERVERTEBRAL SPACE WAS TOO NARROW FOR TRIAL INSERTION. THREE ATTEMPTS WERE MADE TO PLACE THE L4/5 CAGE, BUT IT COULD NOT BE PLACED PROPERLY. THE BROKEN PARTS OF THE CAGE AND INSERTER WERE REMOVED, AND THE INSERTER AND CAGE WERE CHANGED AND INSERTION WAS DONE AGAIN, BUT THE CAGE GOT BROKEN AGAIN. A NEW CAGE WAS TAKEN OUT AND INSERTION WAS TRIED FOR THE THIRD TIME. HOWEVER, HALFWAY THROUGH THE INSERTION (WHEN THE CAGE WAS ABOUT HALFWAY INSERTED BETWEEN THE VERTEBRAE), THE INSERTER AND CAGE COULD NO LONGER BE GRASP

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16191527 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT OLIF (OBLIQUE LUMBAR INTERBODY FUSION) AT L4/5 DUE TO ISTHMIC SPONDYLOLISTHESIS. INTRA-OP, AFTER INSERTING THE CAGE WITH THE INSERTER, THE CAGE PARTIALLY BROKE WHEN AN ATTEMPT WAS MADE TO PULL IT BACK WITH THE SLAP HAMMER WHICH WAS ATTACHED TO THE INSERTER IN ORDER TO MAKE A SLIGHT ADJUSTMENT. LATER, THE SURGEON REPLACED THE REMOVAL INSTRUMENT TO A REMOVER AND AGAIN TRIED TO REMOVE THE CAGE. HOWEVER, GRIPPING COULD NOT BE DONE AND THE CAGE COULD NOT BE REMOVED. THEREFORE, REST OF THE PART OF THE CAGE REMAINED IMPLANTED. THE OVERALL PROCEDURE WAS DELAYED BY LESS THAN 60 MINS. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9584691 ↗
• MalfunctionNov 19, 2019Break; Break

  PRE OP DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE SCHEDULED AS: OLIF L2-5 W/ MI-GUIDED RIGHT L3/4 LAMINECTOMY POSTERIOR FUSION L2-5 W/ PEDICLE SCREW FIXATION. CAGE WHICH WAS BROKEN, IMPLANTED AT LEVEL L3/4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9339663 ↗
• MalfunctionJul 5, 2019Break; Break

  PROCEDURE- INTERVERTEBRAL LUMBAR FUSION IT WAS REPORTED THAT INTRA-OP, WHEN ATTEMPTING TO INSERT A LUMBAR SPACER IN THE LATERAL POSITION, THE IMPLANT BROKE INTO MULTIPLE PIECES. BROKEN PIECES WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8763641 ↗
• MalfunctionMay 24, 2019Break; Break

  THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF25), INTRA-OP, DURING INSERTION WHEN TAPPED WITH A MALLET THE CAGE CRACKED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639685 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: ANTERIOR SPINAL FIXATION PRE-OPERATIVE DIAGNOSIS: KYPHOSCOLIOSIS LEVEL IMPLANTED: L2-L5 IT WAS REPORTED THAT, POST-OP, THE CAGE BETWEEN L 4/5 TOUCHED NERVE ROOT OF THE RIGHT SIDE OF L5 OR CAUDA EQUINA NERVE.THE CAGE DID NOT BACK OUT. NERVE ROOT SYMPTOM OCCURRED AFTER THE OPERATION, REOPERATION WAS PERFORMED AND CAGE WAS REMOVED.

  Patient problems: Nerve Damage

  MAUDE report 8135773 ↗
• InjuryAug 9, 2018Migration; Migration

  LEVELS IMPLANTED: L1-L5 IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION SURGERY ON (B)(6) 2018 DUE TO KYPHOSCOLIOSIS. POST-OP, WHEN PERFORMING POSITION SETTING OF POSTERIOR FIXATION, IT WAS CONFIRMED THAT THE CAGE AT L1/2 BACKED OUT TO THE LEFT SIDE (THE ENTRANCE SIDE) BY ABOUT 2/5 OF THE WHOLE. SO PLIF AT L5/S WAS PERFORMED AND SCREW WAS INSERTED TO T9-S2AI FIRST. AFTER THAT, THE POSITION WAS CHANGED, AND THE CAGE WAS HAMMERED. THE PRODUCT CAME IN THE CONTACT WITH THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7769069 ↗