ReLine 11355035Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517504999), received between Oct 15, 2018 and Apr 15, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• MalfunctionApr 15, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2019 PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION AT S1-L2 LEVELS WITHOUT A REPORTED ISSUES. DURING A ROUTINE FOLLOW UP RADIOGRAPHS IDENTIFIED THAT A ROD PULLED OUT OF THE SET SCREW AT THE BOTTOM OF THE CONSTRUCT. ON (B)(6) 2019 A REVISION PROCEDURE TOOK PLACE, REPLACING THE LOCK SCREW AND SECURING THE ROD. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516680 ↗
• InjuryOct 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, PATIENT UNDERWENT POSTERIOR FUSION AT THE L3-L4 VERTEBRAL LEVELS. SEVERAL MONTHS POST-OPERATIVE PATIENT WAS EXPERIENCING BACK PAIN AND UPON EVALUATION AN INFECTION WAS CONFIRMED. ON (B)(6) 2018, ALL THE IMPLANTED DEVICES WERE REMOVED. AS PER REPORTER ONCE THE PATIENT RECOVERS, POSTERIOR FUSION USING AUTOLOGOUS BONE TRANSPLANTATION, WITHOUT ANY IMPLANT DEVICE, WILL BE PERFORMED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7967213 ↗