CLYDESDALE PTC™ Spinal System 4986840Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169190542), received between Aug 22, 2017 and Oct 8, 2024 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT PATIENT UNDERGOING OLIF OBLIQUE-LATERAL LUMBAR INTERBODY FUSION THERAPY FOR ADULT SPINAL DEFORMITY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED AT T12-L5 IT WAS REPORTED THAT HERE WAS AN ERROR IN THE LEVEL L2/3 DURING THE OLIF IMPLEMENTATION PROCESS, SO A CAGE WAS INSTALLED IN L1/2 WHERE THE PROCEDURE HAD ALREADY BEEN PERFORMED, AND THE PREVIOUSLY INSTALLED CAGE DISLODGED TO CONTRALATERAL SIDE. THERE WAS LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE CAGE THAT WAS ORIGINALLY INSTALLED IN L1/2 WAS PUSHED TO THE OPPOSITE SIDE. A CAGE WAS INSTALLED IN L2/3 AND THE WOUND WAS CLOSED. THE CAGE THAT DEVIATED TO THE OPPOSITE SIDE WAS REMOVED BY THE RIGHT APPROACH. THERE WAS NO INITIAL DEFECT WITH THE PRODUCT . ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION OR ALLEGATION ASSOCIATED WITH O-ARM OR ANY NAVIGATION DEVICE. IT IS THOUGHT THE THE WRONG LEVEL INSTALLATION WAS DUE TO THE USER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397216 ↗
• MalfunctionOct 20, 2021Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR SCOLI OSIS. IT WAS REPORTED THAT AFTER PLACING THE DD, THEY TRIED TO REMOVE IT BECAUSE IT WAS A LITTLE DEEPER POSTERIOR, BUT THE PART CONNECTING CAGE AND THE REMOVER WAS BROKEN AND THEY COULD ONLY REMOVE THE PRODUCT HALFWAY, SO THEY HAD NO CHOICE BUT TO INSERT THE PRODUCT AGAIN AS IT WAS. PROCEDURE INVOLVED IN THE EVENT WAS OBLIQUE LATERAL INTERBODY FUSION (OLIF) AND LEVELS IMPLANTED WAS L1/2.THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT CAGE'S INSTRUMENT CONNECTION PART WAS DEFORMED, THERE IS ONLY THE POSSIBILITY OF BREAKAGE. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT. THE PRODUCTS ARE UNDER IMPLANTATION AND NO PLAN TO RETURN THE PRODUCTS.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664152 ↗
• InjuryDec 22, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DEGENERATIVE SCOLIOSIS TYPE OF PROCEDURE BEING PERFORMED : POSTERIOR DECOMPRESSION FUSION, OBLIQUE LUMBAR INTERBODY FUSION LEVELS: L2/3 IT WAS REPORTED THAT INTRA-OP, O-ARM IMAGE REVEALED THAT THE CAGE POSITION WAS IN THE SPINAL CANAL BEFORE CLOSURE. IT WAS REMOVED IMMEDIATELY, AND THE INCISION WAS CLOSED. THE CAGE BROKE. AGGRAVATION OF NEUROLOGICAL SYMPTOMS IN THE PATIENT WAS OBSERVED NEXT DAY.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7141652 ↗
• MalfunctionOct 26, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3-5 DUE TO LUMBAR DEGENERATIVE SCOLIOSIS. DURING INSERTION, THE CAGE BROKE. THE CAGE WAS INSERTED TO INSERTER FOR L3/4, IT COULD NOT BE REMOVED FROM THE INSERTER THEREAFTER. THE SURGEON TRIED TO REMOVE IT FORCIBLY AND THE EDGE OF THE CAGE BROKE. THE FRAGMENTS WERE SECURED AND OTHER THAN THAT IT REMAINED IN THE PATIENT. WHEN THE SAME INSERTER WAS USED FOR L4/5 TO INSERT THE CAGE, THERE WAS NO TROUBLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978959 ↗
• MalfunctionAug 22, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH PREOPERATIVE DIAGNOSIS OF SPINAL CANAL STENOSIS AND KYPHOSIS UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF). INTRA-OP, WHEN THE SPINAL CAGE WAS TRIED TO BE INSERTED IN L1/2 USING INSERTER, IT BROKE NEAR THE ENTRANCE. SINCE THE INTERVERTEBRAL SEGMENT WAS VERY TIGHT, THE CAGE WAS HAMMERED WITH SLIGHTLY STRONG FORCE. THE INTERVERTEBRAL DISC WAS SO NARROWED THAT A COBB COULD NOT BE INSTALLED ON THE OTHER SIDE. AS RIBS AND PERITONEUM DISTURBED INSERTION OF CAGE, THE CAGE COULD NOT BE INSERTED PARALLEL TO THE INTERVERTEBRAL DISC. THE SURGEON INSERTED CAGE FROM THE CAUDAL SIDE TO THE CRANIAL SIDE, AND CAGE WAS BROKEN. THIS WAS EXPLANTED. EVEN TRIAL WAS NOT CARRIED OUT. THEN, NEW CAGE WAS PREPARED. IN THIS TIME, TRIAL WAS CONDUCTED AND THE TAB OF THE INSERTER WAS INSERTED ALL THE WAY. AS A RESULT, THE NEW ONE COULD BE INSERTED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809421 ↗