Reliance Posterior Cervical Thoracic System 5-00-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842566104170), received between Jun 9, 2022 and Jun 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• MalfunctionJun 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  RELIANCE PCT SET SCREW, TI, IS PART OF THE RMS PCT 3.5 SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE LOOSE SET SCREW, (B)(6) 2022 VIA TEXT MESSAGE FROM DR. (B)(6). IMPLANTATION OF DEVICE WAS PERFORMED IN 2022 BY DR. (B)(6). DR (B)(6) DISCOVERED THE A SET SCREW HAD COME OFF A PCT SCREW, AT C2, ABOUT 1 MONTH POST-OP. PHYSICIAN REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT, AND "HE IS DOING VERY WELL CLINICALLY SO NO PLANS TO REMOVING/REVISING." IT IS UNKNOWN WHEN OR HOW THE SET SCREW CAME OFF THE PCT SCREW. DR (B)(6) REPORTED "PATIENT DOESN'T RECALL ANY TRAUMA OR ANYTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640596 ↗