ANATOMIC PEEK PTC Cervical Fusion System 5030641Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169357556), received between Aug 21, 2024 and Mar 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 26, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR C4-6 CSM. IT WAS REPORTED THAT AFTER INSERTING THE 6 MM CAGE WITH THE HAMMERING, THE TRIANGLE MARK WAS REVERSED, SO IT WAS IMPLANTED UPSIDE DOWN. THE INSERTER WAS USED TO GRASP AND REMOVAL WAS ATTEMPTED, BUT THE SCREW HOLE WAS STRIPPED AND COULD NOT BE REMOVED, SO EVEN WHEN IT WAS INSTALLED IN THE REVERSE DIRECTION, IT FIT THE VERTEBRAL BODY, SINCE THE LORDOTIC ANGLE IS OBTAINED, IT WAS IMPLANTED AS IT IS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS CERVICAL SPINE ANTERIOR DECOMPRESSION AND FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696628 ↗
• MalfunctionNov 26, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACDF AT C4/5. IT WAS REPORTED THAT THE SCREW THREAD ON THE CAGE SIDE WAS DEFORMED. AFTER THE PRODUCT WAS ATTACHED TO THE INSERTER, IT WAS INSERTED USING A HAMMER INSIDE THE BODY. AT THAT TIME, ONLY THE INSERTER ROTATED AND COULD NOT BE PROPERLY GRASPED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSERTERS HAD POOR GRIP. ALL THE MOVEMENTS IN THE JOINT AREA WERE BAD FOR THE CAGE, INSTRUMENT SHAFT AND INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788625 ↗
• MalfunctionAug 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE HAS BROKEN. AFTER IMPLANTATION, WHEN REMOVING INSERTER FROM IMPLANT, SURGEON OBSERVED PEEK SHAVINGS FROM THE HOLE WHERE INSERTER ATTACHES TO IMPLANT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE IS NO PLAN FOR REVISION SURGERY OR EXTENDED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020608 ↗