CONCORDE 187823109Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034139340), received between Feb 12, 2019 and Jan 13, 2025 — classified as 4 injuries, 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA PHONE TODAY. UPON CONTACT WITH THE HOSPITAL, THE PATIENT HAD LOWER EXTREMITY PAIN AFTER LUMBAR FUSION SURGERY, AND WAS UNABLE TO WALK INDEPENDENTLY WHEN THE SYMPTOMS WORSENED (SPECIFIC EVENT DATE COULD NOT BE VERIFIED), AND THE HOSPITAL DID NOT PROVIDE MORE DETAILS ABOUT THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139713 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE LUMBAR FUSION SURGERY, THE PRODUCT WAS IMPLANTED INTO THE PATIENT. FOUR YEARS LATER, THE PATIENT DEVELOPED LEFT LOWER EXTREMITY PAIN AND INABILITY TO WALK INDEPENDENTLY. IT WAS SUSPECTED THAT THE INFECTION OCCURRED AFTER IMPLANTATION OF THE PRODUCT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139708 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE LUMBAR FUSION SURGERY, THE PRODUCT WAS IMPLANTED INTO THE PATIENT. FOUR YEARS LATER, THE PATIENT DEVELOPED LEFT LOWER EXTREMITY PAIN AND INABILITY TO WALK INDEPENDENTLY. IT WAS SUSPECTED THAT THE INFECTION OCCURRED AFTER IMPLANTATION OF THE PRODUCT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139707 ↗
• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THREE (3) CONCORDE BUL PARS BROKE. CAGES WERE DEFRAGMENTED DURING THE TRIAL TO PUT THEM IN THE INTERVERTEBRAL SPACE SO THEY WEREN¿T REMOVED AFTER IMPLANTATION. NO CONSEQUENCES FOR THE PATIENT REPORTED. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED ANOTHER ONE TYPE PRODUCT. THERE WAS NO DELAY DURING THE PROCEDURE. THIS REPORT IS FOR ONE (1) CONCORDE BUL PAR 9X9X23. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462358 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING AN L4-5 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), THE SURGEON HAD INCREASED BLEEDING WHILE WORKING IN THE INTERBODY SPACE. THE PEDICLE SCREWS ON THE CONTRALATERAL SIDE HAD ALREADY BEEN PLACED AND THE SCREW HOLES WERE MADE ON THE IPSILATERAL (SAME) SIDE OF THE TLIF BUT HAD NOT BEEN PUT IN YET. THE SURGEON NOTICED A SIGNIFICANT AMOUNT OF BLEEDING WHILE USING THE MEDTRONIC NAVIGATION PROBE IN THE DISC SPACE. IT WAS CONTROLLED BUT OOZING DURING THE ENTIRE PORTION OF THE CASE. THE PROBE HAD BROKEN THROUGH THE ANTERIOR PORTION OF THE DISC SPACE WHICH COULD HAVE LED TO THE BLEEDING. AN OPAL 10X28X8MM CAGE WAS PLACED BY THE SURGEON, A ROD THEN PLACED ON THE SAME SIDE, AND THEN THEY SPUN THE O-ARM WHICH IS A 3D IMAGE OF THE SPINE. THE LATERAL IMAGE CONFIRMED THAT THE SURGEON PLACED THE CAGE TOO FAR ANTERIOR IN THE DISC SPACE SO HE ATTEMPTED TO REMOVE THE CAGE POSTERIORLY. AS HE ATTEMPTED THIS, HE NOTICED INCREASED BLOOD LOSS SO HE DECIDED TO CALL A VASCULAR SURGEON TO COME IN TO ASSIST. THE PATIENT WAS CLOSED FROM THE BACK, THEN FLIPPED SUPINE, AND THE VASCULAR SURGEONS ACCESSED THE SPINE ANTERIORLY TO SEE WHAT WAS CAUSING THE BLEEDING. THEY WE

  Patient problems: Blood Loss; Injury; No Code Available

  MAUDE report 8332480 ↗