ReLine 16025540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517556264), received between Mar 25, 2019 and May 4, 2021 — classified as 1 injury, 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 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.

• MalfunctionMay 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT TH10-L4. THE PATIENT WAS ASYMPTOMATIC AND IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP THAT ONE OF THE IMPLANTED PEDICLE SCREWS HAD BECOME LOOSE. ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO ADDRESS THE LOOSENED PEDICLE SCREW AT L2. IN THE REVISION SURGERY, PEDICLE SCREWS FROM L2 TO L4 WERE REPLACED WITH NEW ONES AND NEW PEDICLE SCREWS WERE ADDED AT L5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773336 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT UNDERWENT A POSTERIOR SPINAL FUSION FROM TH9-ILIAC LEVELS. AS PER REPORTER WHEN ATTEMPTING TO PLACE A ROD, PATIENT WENT INTO CARDIAC ARREST. PROCEDURE WAS COMPLETED WITHOUT PLACING A ROD. ON (B)(6) 2019, AN ADDITIONAL PROCEDURE WAS PERFORMED, AND RODS WERE PLACED. NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 8448657 ↗