ANATOMIC PEEK PTC Cervical Fusion System 5030141Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169357624), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. PRE-OP DIAGNOSIS WAS CERVICAL KYPHOSIS. IT WAS REPORTED THAT, PATIENT HAD DISCOMFORT DUE TO PLATE DISLODGEMENT. AFTER C5/6 DECOMPRESSION, 11MM CAGE WAS PLACED AND MIGRATION OF C5/6 CAGE ALREADY OCCURRED AFTER COMBINED POSTERIOR FIXATION. AFTER 1 WEEK POSTOPERATIVELY, FURTHER MIGRATION OF THE CAGE AND HEAD SIDE DISLODGEMENT OF THE C4-7 ZEVO PLATE OCCURRED. TOTAL REMOVAL OF PLATE AND REMOVAL OF  11MM CAGE AT C5/6, AUTOLOGOUS ILIAC BONE TRANSPLANTATION BETWEEN C5/6 VERTEBRAE WAS RETRIEVED DURING REVISION SURGERY.  THE 13MM SCREW AT C4 AND 15MM SCREW AT C7 WAS FOUND LOOSE AND THEY WERE EXPLANTED. PROCEDURE OR TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS C4-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION. THERE WERE NO PARTICULAR PROBLEMS WITH 5MM CAGE.  NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19094240 ↗