Reliance Anterior Cervical Plate System 4-01-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842566102275), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionJan 19, 2018Bent; Bent

  RELIANCE COVER PLATE ASSEMBLY IS PART OF THE RELIANCE ANTERIOR CERVICAL PLATE SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE COMPLAINT TUESDAY, (B)(6) 2017 VIA TEXT MESSAGE FROM FIELD REP. (B)(6). IMPLANTATION OF DEVICE WAS PERFORMED (B)(6) 2017 BY DR. (B)(6) AT (B)(6) HOSPITAL. PATIENT FELL AT HOME TWO MONTHS BEFORE REVISION SURGERY. PATIENT DIDN'T COME IN TO GET HIS NECK CHECKED OUT UNTIL A WEEK BEFORE THE REVISION SURGERY. PATIENT REPORTED HAVING PAIN IN NECK. SENIOR ENGINEER AT RELIANCE MEDICAL SYSTEMS REVIEWED THE RETURNED COVER PLATE ASSEMBLY. HE STATED, "WHEN THE CERVICAL BONE SCREWS BACKED OUT OF THE VERTEBRAL BODY, THEY PUSHED THE COVER PLATE AWAY FROM THE CERVICAL PLATE. THIS BENT THE COVER PLATE AND DAMAGED THE LOCKING SCREW FOR THE COVER PLATE. HOWEVER, BOTH THE LOCKING SCREW AND THE COVER PLATE REMAINED INTACT, AND THE CERVICAL BONE SCREWS REMAINED PARTIALLY EMBEDDED IN THE VERTEBRAL BODY." REVISION SURGERY WAS PERFORMED BY THE SAME PHYSICIAN ON (B)(6) 2017 AT THE SAME HOSPITAL.

  Patient problems: Pain

  MAUDE report 7207258 ↗