ReLine 15355300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517509949), received between Jun 29, 2020 and Nov 17, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2020Fracture; Fracture

  THE DEVICE WAS RETURNED AND EVALUATED, UPDATED INFORMATION CAN BE FOUND IN SECTIONS:

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10852879 ↗
• InjuryJul 22, 2020Fracture; Fracture

  ON JUNE 24, 2020, INFORMATION WAS RECEIVED THAT PATIENT EXPERIENCED BI-LATERAL ROD FRACTURES. AS PER REPORTER, EXCESSIVE WEIGHT MAY BE TRANSFERRED TO THE RODS. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10312056 ↗
• MalfunctionJun 29, 2020Fracture; Fracture

  AS PER REPORT PATIENT WAS EXPERIENCING PAIN AND SIGNS OF SCREW LOOSENING. ON (B)(6) 2020, PATIENT UNDERWENT A REVISION PROCEDURE WHERE A BROKEN ROD IDENTIFIED.

  Patient problems: Pain

  MAUDE report 10209128 ↗