Reliance Spinal Screw System 6-02-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842566105108), received between Jun 28, 2017 and Jun 28, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 28, 2017Fracture; Fracture

  PATIENT REPORTED HAVING A TITANIUM ROD BREAK IN EARLY (B)(6) 2016. RELIANCE PSS TI ROD, STRAIGHT, 6.0X400MM IS PART OF THE RMS PEDICLE SCREW SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE BROKEN ROD (B)(4) 2017 VIA EMAIL. IMPLANTATION OF DEVICE WAS PERFORMED (B)(6) 2016 BY DR. (B)(6) AT (B)(6) FOR AN UNSTABLE L1 FRACTURE. THE PATIENT REPORTED SWIMMING AND AQUA FIT SESSION THREE TIMES A WEEK AND BEING ABLE TO RETURN TO PLAYING GOLF AFTER THE ORIGINAL PROCEDURE PRIOR TO THE ROD BREAKING. PATIENT REPORTED HE WAS STANDING AT HIS KITCHEN COUNTER BREWING TEA. PATIENT REACHED OVER TO HIS RIGHT AND HEARD A LOUD "CRACKING NOISE" COMBINED WITH SHARP BACK PAIN. PATIENT WENT TO PHYSICIAN PROVIDING HIS POST-OPERATIVE CARE, DR. (B)(6), CHIEF NEUROSURGEON AT (B)(6) FOR X-RAYS. AFTER REVIEWING THE X-RAYS, DR. (B)(6) DID NOT FEEL A REVISION SURGERY WAS INDICATED SINCE THE BACK HAD ALREADY 6 MONTHS TO HEAL AND THE SECOND ROD WAS STILL IN PLACE. DR. (B)(6) WANTED TO REVIEW AGAIN AFTER 5-6 MONTHS, WHICH REVEALED THE SECOND ROD STILL IN PLACE WITHOUT BREAK AND THE BROKEN ROD WITHOUT SHIFT OR MOVEMENT. A FINAL VISIT IS SCHEDULED IN 12 MONTHS.

  Patient problems: Pain

  MAUDE report 6675497 ↗