ReLine 10060445Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517535078), received between Feb 9, 2017 and Sep 16, 2022 — classified as 1 injury, 1 malfunction.

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

• InjurySep 16, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THAT PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON ATTEMPTED TO TIGHTEN THE LOCKING CAM OF THE CROSS CONNECTOR ON THE ROD, THE CAM SPUN AND WAS UNABLE TO BE TIGHTENED. SUBSEQUENTLY, THE SURGEON ENCOUNTERED DIFFICULTIES IN REMOVAL OF THE CONNECTOR AND HAD TO USE A LESKAL TO RIP THE DEVICE OUT OF THE CONSTRUCT, RESULTING IN A BROKEN PEDICLE. AS A RESULT, THE FUSION HAD TO BE EXTENDED. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Vertebral Fracture

  MAUDE report 15442596 ↗
• MalfunctionFeb 9, 2017Fracture; Fracture

  A FEMALE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON (B)(6) 2016. SHORTLY AFTER THIS PROCEDURE SHE SAT DOWN HARD ON A SEAT THAT WAS LOWER THAN EXPECTED AND NOTICED PAIN AND A LOUD SNAPPING/CRACKING SENSATION. EVALUATION INCLUDED RADIOGRAPHS WHICH NOTED ROD-TO-ROD CONNECTOR HAD FRACTURED. ON (B)(6) 2016 SHE HAD A REVISION SURGERY TO REMOVE AND REPLACE THE FRACTURED DEVICE.

  Patient problems: Failure of Implant; Fall; Pain

  MAUDE report 6316176 ↗