Reliance Cervical IBF-S System 2-S40-DV14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842566102107), received between Oct 22, 2018 and Oct 22, 2018 — classified as 1 malfunction.

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.

• MalfunctionOct 22, 2018Migration; Migration

  CERVICAL IBF-S, SCREW, DRILLING VARIABLE, 4.0, 14MM IS PART OF THE RELIANCE CERVICAL IBF-S SYSTEM. RELIANCE MEDICAL SYSTEMS (RMS) WAS MADE AWARE OF THE COMPLAINT WEDNESDAY, (B)(6) 2018 VIA PHONE CALL TO RMS ACCOUNT MANAGER (B)(4) FROM FIELD REP. (B)(4). IMPLANTATION OF THE DEVICE WAS PERFORMED (B)(6) 2018 BY DR. (B)(46 AT (B)(6). PATIENT WENT TO THREE MONTH CHECK UP WITH DR. (B)(6), WHILE THERE THE PATIENT REPORTED TO THE PHYSICIAN THAT HE WAS EXPERIENCING DYSPHASIA. X-RAYS WERE TAKEN AND IT WAS DISCOVERED ONE OF THE SCREWS HAD BEGUN TO BACK OUT. REVISION PROCEDURE WAS PERFORMED (B)(6) 2018 BY DR. (B)(6) TO REMOVE THE SCREW THAT HAD BEGUN TO BACK OUT. ENGINEERING MANAGER (B)(4) AT RMS DISCUSSED THE REVISION PROCEDURE WITH DR. (B)(6). (B)(4) STATED, "THE SURGEON SAID THAT, ALTHOUGH THE ABUNDANCE OF TISSUE GROWTH AROUND THE IMPLANT LIMITED HIS VIEW, HE DID NOT NOTICE ANY DISCERNIBLE BREAKAGE OF THE IBF PEEK IMPLANT. HE FELT THE FUSION AROUND THE IMPLANT WAS MATURE ENOUGH TO RETAIN THE PEEK IMPLANT WITHOUT FURTHER REINFORCEMENT VIA BONE SCREWS. THEREFORE, ONLY THE SCREW THAT BACKED OUT OF THE IMPLANT WAS REMOVED."

  Patient problems: Dysphasia

  MAUDE report 7993258 ↗