EXPEDIUM 196791320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034295299), received between Jul 26, 2018 and Jan 18, 2023 — classified as 3 injuries.

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

• InjuryJan 18, 2023Break; Migration; Break; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: THE DR. OPERATED ON PATIENT ON (B)(6) 2022. WHEN REVISING THIS CONSTRUCT IT WAS NOTED THAT THE LEFT LUMBAR ROD HAD BROKEN. ROD WAS REMOVED AND REPLACED WITH A COCR ROD AND NEW SET SCREW USED TO LOCK DOWN THIS CONSTRUCT. THIS REVISION WAS A REVISION OF A 2019 AND 2017 CONSTRUCT. I HAVE INCLUDED THE ROD FROM THE 2017 CASE BUT THIS CASE WAS REVISITED IN 2019 AND I WAS NOT MADE AWARE OF THIS. PATIENT STATUS/ OUTCOME/CONSEQUENCES: THERE WAS A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT; A BROKEN ROD. THIS REPORT IS FOR ONE (1) EXP5.5 320MM CONTOUR COCR ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16194348 ↗
• InjuryJul 26, 2018Break; Break

  PATIENT REPORTED PROBLEM WITH DEPUY SYNTHES HARDWARE AND DR. (B)(6) SCHEDULED REVISION SURGERY FOR (B)(6) 2018. DS RODS WERE BROKEN ABOVE THE L1 PEDICLE SCREWS. SURGEON REMOVED BROKEN RODS AND 3 OF THE 4 DS CONNECTORS. ADDITIONAL RODS AND CONNECTORS WERE USED TO REPLACED THE BROKEN HARDWARE. REVISION WENT AS PLANNED. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION: PAINFUL HARDWARE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Spinal Column Injury

  MAUDE report 7721685 ↗
• InjuryJul 26, 2018Break; Break

  PATIENT REPORTED PROBLEM WITH DEPUY SYNTHES HARDWARE AND DR. (B)(6) SCHEDULED REVISION SURGERY FOR (B)(6) 2018. DS RODS WERE BROKEN ABOVE THE L1 PEDICLE SCREWS. SURGEON REMOVED BROKEN RODS AND 3 OF THE 4 DS CONNECTORS. ADDITIONAL RODS AND CONNECTORS WERE USED TO REPLACED THE BROKEN HARDWARE. REVISION WENT AS PLANNED. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION: PAINFUL HARDWARE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7721682 ↗