CLYDESDALE PTC™ Spinal System 4922255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169191310), received between Oct 9, 2018 and Apr 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DIRECT LATERAL INTERBODY FUSION (DLIF) APPROACH. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. WHILE THE SURGEON WAS IMPLANTING THE PRODUCT, WE NOTICED THE INSERTER/IMPLANT MADE A DISTINCT NOISE. AFTER LOOKING AT THE XRAY, WE NOTICE THE INSERTER WAS BENT AND THE IMPLANT WAS DAMAGED. SO, WE ARE NOT SURE IF THE IMPLANT CAUSED THE INSERTER TO BEND OR IF THE INSERTER BENDING CAUSED THE IMPLANT TO BREAK. THE MALLETS WERE BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT IT WAS A FAILURE ON THE INSERTER PRONGS THAT CREATED THE BREAKAGE/FAILURE ON THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132219 ↗
• MalfunctionOct 9, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR SPINAL CANAL STENOSIS TYPE OF PROCEDURE OR TECHNIQUE USED: ANTERIOR LUMBAR FUSION AND POSTERIOR LUMBAR FUSION IT WAS REPORTED THAT INTRA-OP, THREAD OF THE CAGE WAS DEFORMED OR BROKEN. INTRA-OPERATIVELY, AFTER CLEANING UP THE INTERVERTEBRAL DISC, WHEN ABOUT 90% OF THE CAGE WAS INSERTED AT L4-5, IT WAS DIFFICULT TO INSERT THE CAGE DEEPER. THE PHYSICIAN TRIED TO HIT THE INSERTER TO CONTRALATERAL SIDE WITH A HAMMER IN ORDER TO REMOVE THE CAGE, HOWEVER IT COULD NOT BE REMOVED. THE CAGE WAS THEN REMOVED BY REMOVAL IMPLEMENT AND THE INTERVERTEBRAL DISC WAS CURETTED AGAIN. WHEN TRYING TO ATTACH THE CAGE TO THE INSERTER AGAIN, THE CAGE COULD NOT BE GRIPPED DUE TO PROBABLE BREAKAGE OF THREAD OF THE CAGE. A NEW CAGE WAS THEN OPENED TO DEAL WITH THIS PROBLEM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948896 ↗