ReLine 13016550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517537225), received between Nov 16, 2018 and Jul 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2019Break; Break

  ON (B)(6) 2018 A PATIENT UNDERWENT A SPINAL PROCEDURE AT THE L5 TO S1 VERTEBRAL LEVELS. THE PROCEDURE WENT AS PLANNED WITH NO ISSUES. DURING THE PATIENT'S 30 DAY POST-OPERATIVE VISIT THERE WERE NO ISSUES OR EVIDENCE OF ANY IMPLANT FAILURES. APPROXIMATELY EIGHT TO NINE MONTHS POST-OPERATIVE, THE PATIENT BEGAN TO EXPERIENCE BACK PAIN. IT WAS DISCOVERED THERE WAS A BILATERAL SCREW BREAKAGE AT THE S1 LEVEL. PRIOR TO THIS THE PATIENT WAS ASYMPTOMATIC. THE PATIENT'S CURRENT STATUS IS UNKNOWN AND IT IS UNKNOWN IF A REVISION OCCURRED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8750760 ↗
• MalfunctionNov 16, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2018 PATIENT UNDERWENT A REVISION PROCEDURE INVOLVING POSTERIOR FIXATION WITHOUT DISCECTOMY/FUSION. POST-OPERATIVE THE PATIENT CONTINUED TO EXPERIENCE ONGOING PAIN. AS PER REPORTER PAIN IS BELIEVED TO BE RELATED TO SCREW MALPLACEMENT. DATE OF INDEX PROCEDURE IS UNKNOWN.

  Patient problems: Claudication; Pain

  MAUDE report 8078960 ↗