ReLine 13119540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517583338), received between Nov 1, 2022 and Nov 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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.

• InjuryNov 1, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED SYMPTOMS OF PAIN APPROXIMATELY FIVE (5) MONTHS LATER AND EXAMINATION IDENTIFIED THAT BOTH PEDICLE SCREWS AT S2 HAD FRACTURED. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE FRACTURED SCREWS. DURING THE REVISION PROCEDURE, IT WAS IDENTIFIED THAT BOTH SCREWS AT S1 HAD LOOSENED AND FUSION HAD FAILED TO OCCUR AT THE L5/S1 DISC SPACE. THE SCREWS AT S1 WERE REMOVED AND REPLACED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15712723 ↗
• InjuryNov 1, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED SYMPTOMS OF PAIN APPROXIMATELY FIVE (5) MONTHS LATER AND EXAMINATION IDENTIFIED THAT BOTH PEDICLE SCREWS AT S2 HAD FRACTURED. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE FRACTURED SCREWS. DURING THE REVISION PROCEDURE, IT WAS IDENTIFIED THAT BOTH SCREWS AT S1 HAD LOOSENED AND FUSION HAD FAILED TO OCCUR AT THE L5/S1 DISC SPACE. THE SCREWS AT S1 WERE REMOVED AND REPLACED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15712722 ↗