CLYDESDALE PTC™ Spinal System 4986040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169190740), received between Nov 8, 2018 and Mar 11, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/3/4 OLIF FOR SPINAL CANAL STENOSIS ASSOCIATED WITH DEGENERATIVE SPONDYLOLISTHESIS AND VERTEBRAL FRACTURE. IT WAS REPORTED THAT CAGE SIZE WAS SELECTED AS A TRIAL, AND WHEN THE PHYSICIAN OPENED THE CAGE AND INSTALLED IT TO THE INSERTER, IT COULD NOT BE PROPERLY INSTALLED. IT WAS TRIED AGAIN, BUT IT WAS INSTALLED AT AN ANGLE, SO A NEW CAGE WAS OPENED. THERE WAS NO PARTICULAR ABNORMALITY AT THE TIP OF THE INSERTER, SO WHEN A NEW CAGE WAS INSTALLED, IT WAS PROPERLY INSTALLED AND THE SURGERY WAS CONTINUED WITHOUT ANY PROBLEMS. INSERTER WAS CONNECTED DIAGNALLY WITH THE CAGE.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 21571357 ↗
• InjurySep 21, 2023Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE WILL BE RETURNED TO THE CUSTOMER AND IT WON'T BE RETURNED TO BU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787150 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR KYPHOSCOLIOSIS TYPE OF PROCEDURE OR TECHNIQUE USED: OLIF (OBLIQUE LUMBAR INTERBODY FUSION) LEVELS IMPLANTED: L2/3/4 IT WAS REPORTED THAT INTRA-OP, AFTER IMPLANTATION WAS COMPLETED, WHEN PERFORMING HEMOSTASIS TO THE BLEEDING FROM THE END PLATE OF VERTEBRAL BODY, THE SOMATIC ARTERY WAS INJURED CAUSING BLOOD LOSS OF ABOUT 500-600ML. HEMOSTASIS WAS PERFORMED WITH FACILITY OWNED TWEEZER AND GAUZE. THE WOUND WAS CLOSED BY SPRINKLING THE FLOSEAL AFTER HEMOSTASIS WITH ASTRICTION OR CAUTERIZATION. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT DUE TO THE ADVERSE EVENT. NO MALFUNCTION WAS REPORTED FOR THE PRODUCT; AND THE INJURY WAS NOT CAUSED DUE TO THE PRODUCT. POSTERIOR FUSION WAS PLANNED TO BE PERFORMED; HOWEVER NO INFORMATION IS AVAILABLE IF IT WAS ACTUALLY PERFORMED.

  Patient problems: Blood Loss; Injury

  MAUDE report 8050174 ↗