CONCORDE 187827107Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034139883), received between Mar 28, 2018 and Aug 15, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 15, 2018Break; Break

  9X7X27MM CONCORDE BULLET CAGE BROKE WHILE IMPLANTING. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:BROKEN PIECES LEFT IN PATIENT. COULD NOT BE REMOVED. ACTION TAKEN FOR PROCEDURE:BROKEN PIECES OF CAGE WERE EXTRACTED. THE TIP OF THE BULLET CAGE REMAINED IN PATIENT AS IT COULD NOT BE REMOVED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7784572 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE APPLICATION OF THE LUMBAR CONCORDE BULLET BOX, THE SALES REPRESENTATIVE DID NOT INFORM THE DR. EXACTLY THE CHARACTERISTICS OF THE PRODUCT, ASSUMING THAT HE ALREADY KNEW THE PRODUCT AND HE DID NOT PREVIOUSLY ASK ABOUT IT. AT THE TIME OF INSERTION, THE SPECIALIST DID NOT UNDERSTAND THE SPECIFICATIONS (IT WAS INFORMED BY SALES REP) IMPACTING THE DEVICE UNTIL THE ANTERIOR PART OF THE VERTEBRAE L4 AND L5, WHICH COULD NOT BE RECOVERED AND HE HAD TO LEAVE IT IN A FREE CAVITY AND APPLY ANOTHER IMPLANT FOR THE FUNCTION THAT WAS REQUIRED. THE SPECIALIST INTRODUCED THE IMPLANT UNDER RADIOLOGICAL VISION AND STILL HAS TOO MUCH IMPACT. THE DR WAS NOT BOTHERED AT ANY TIME, BUT IN THE SURGICAL DESCRIPTION HE ARGUED THAT THE INSTRUMENTER OF THE HOUSE TOLD HIM THE MANUFACTURER'S SPECIFICATIONS FOR INSERTION, CLEARING HIS NAME OF ANY LEGAL CIRCUMSTANCE. PATIENT CONSEQUENCE? :YES. PATIENT CONDITION DESCRIPTION: THE DEVICE IS LEFT IN THE ANTERIOR PART OF THE VERTEBRAL BODY. ACTION TAKEN FOR PROCEDURE: IT WAS TRIED TO RECOVER THE IMPLANT, BUT IT WAS IMPOSSIBLE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. PRODUCT INFOR

  Patient problems: Not Applicable; Spinal Column Injury; Tissue Damage

  MAUDE report 7379010 ↗