ReLine 13117535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517582768), received between Sep 12, 2018 and May 15, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION AT TH10-S1 LEVELS WITHOUT REPORTED ISSUES. POST-OPERATIVE, THE PATIENT EXPERIENCED PAIN. AS PER REPORTER IT WAS CONFIRMED THAT A SCREW AT LEFT SIDE OF THE S1 LEVEL WAS IN CONTACT WITH THE NERVE. ON (B)(6) 2019, A REVISION PROCEDURE WAS PERFORMED REPLACING THE S1 SCREW.

  Patient problems: Pain

  MAUDE report 8614200 ↗
• InjurySep 12, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2018, A PATIENT UNDERWENT THE FIRST OF TWO PLANNED PROCEDURES A POSTERIOR LUMBAR INTERBODY FUSION WITH POSTERIOR FIXATION AT L2-S1A1 LEVELS USING ANOTHER MANUFACTURERS CAGES. ON (B)(6) 2018, THE PATIENT UNDERWENT THE SECOND PROCEDURE A VERTEBRAL BODY REPLACEMENT AT L4 LEVEL. POST-OPERATIVE RADIOGRAPHS IDENTIFIED A VERTEBRAL FRACTURE AT THE L3 LEVEL. ON (B)(6) 2018 THE FIRST OF 2 REVISION PROCEDURES WAS PERFORMED REPLACING THE SCREWS AT L2 AND L3 AND EXTENDING THE CONSTRUCT FROM T9-S2A1 LEVELS. ON (B)(6) 2018 THE SECOND PLANNED REVISION PROCEDURE WAS PERFORMED TO REPLACE THE VERTEBRAL BODY REPLACEMENT WITH A LARGER SIZE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7870521 ↗