ReLine 16018580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517554376), received between May 19, 2023 and Aug 20, 2024 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 20, 2024Fracture; Fracture

  ON (B)(6) 2024 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T7-S2AI. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2024 DURING A ROUTINE FOLLOW-UP APPOINTMENT IT WAS DISCOVERED VIA RADIOGRAPH THAT A SCREW AT RIGHT S2AI HAD FRACTURED AT THE NECK OF THE SCREW HEAD. IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING ANY ADVERSE CONSEQUENCES AS A RESULT OF THE DEVICE FAILURE. ON (B)(6) 2024 A REVISION OCCURRED WHERE THE BROKEN SCREW WAS REMOVED AND REPLACED WITH A 10.5X80MM SCREW. THE PATIENTS CURRENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000638 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE FROM T10 TO S2. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2023 IT WAS DISCOVERED VIA RADIOGRAPH DURING A ROUTINE FOLLOW UP THAT THE SHAFT OF THE LEFT S2AI SCREW FRACTURED WHERE THE HEAD MEATS THE TULIP. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC AND NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963678 ↗