ReLine 13016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517537201), received between Jan 4, 2018 and Feb 11, 2026 — classified as 1 injury, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT A PATIENT HAD TWO 6.5X40 MM SCREWS BREAK IN HER S1 VERTEBRA. SHE REPORTS NO INJURIES, SUDDEN MOVEMENTS, OR HIGH-IMPACT EVENTS. THE PATIENT UNDERWENT HER FIRST SURGERY APPROXIMATELY ONE YEAR AGO. THE INITIAL PROCEDURE INVOLVED TWO LEVELS OF REPAIR (L4-S1). FOLLOWING THIS, SHE UNDERWENT A SECOND SURGERY YESTERDAY AFTER THE TWO S1 SCREWS WERE FOUND TO BE BROKEN. DURING THE SECOND SURGERY, POSSIBLE PSEUDOARTHROSIS WAS OBSERVED ON THE LEFT SIDE, WHILE THE RIGHT SIDE WAS WELL-ADHERED. METALLOSIS WAS ALSO OBSERVED ON BOTH SIDES. THIS EVENT OCCURRED IN SPAIN.

  Patient problems: Metal Related Pathology

  MAUDE report 24315374 ↗
• MalfunctionJul 26, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CONSTRUCT WAS EXTENDED AND SCREWS AT S1 LEVEL WERE REPLACED. THE PATIENT WAS ASYMPTOMATIC PRIOR TO REVISION PROCEDURE. NO INJURY OR ADVERSE PATIENT REACTION HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7722485 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2-L4 LEVELS AS WELL AS A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4-S1 WITH POSTERIOR FIXATION FROM L2-S1 LEVELS. A FOLLOW UP RADIOGRAPH SHOWED A VERTEBRAL FRACTURE AT THE S1 LEVEL. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE REMOVING THE S1 SCREW AND EXTENDED THE POSTERIOR FIXATION TO S2 LEVEL WITH NO REPORTED ISSUES. NO PRODUCT MALFUNCTION ALLEGED.

  Patient problems: Bone Fracture(s); Injury; Spinal Column Injury

  MAUDE report 7164032 ↗