ReLine 15460500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517581211), received between Dec 22, 2022 and Jun 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjuryJun 26, 2023Fracture; Fracture

  IT WAS REPORTED A PATIENT UNDERWENT A T4 TO S2AI POSTERIOR FIXATION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT EXPERIENCED POST-OPERATIVE PAIN AND AN X-RAY REVEALED ONE OF THE RODS HAD FRACTURED AT L3/4. A REVISION SURGERY WAS PERFORMED; HOWEVER, IT WAS REPORTED THE BROKEN ROD WAS NOT REMOVED BUT INSTEAD, AN AUXILIARY ROD WAS INSTALLED ADJACENT TO THE BROKEN ROD. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17198352 ↗
• InjuryDec 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EIGHT (8) LEVEL POSTERIOR FIXATION PROCEDURE FROM T10 TO ILIAC WITH VERTEBRAL BODY REPLACEMENT OF L4. SUBSEQUENTLY, THE PATIENT REPORTED SYMPTOMS OF PAIN IN THE BACK AND BILATERAL ANTERIOR THIGHS APPROXIMATELY TWENTY-ONE (21) MONTHS LATER. EXAMINATION IDENTIFIED FRACTURE OF THE LEFT ROD BETWEEN THE L4/L5 LEVELS. A REVISION PROCEDURE TO CORRECT THE CONSTRUCT WAS SCHEDULED; HOWEVER, IT IS UNKNOWN IF THE PATIENT WAS REVISED AT THE TIME OF THIS REPORT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16040627 ↗