CONCORDE 187823408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034139494), received between Aug 17, 2017 and Oct 28, 2020 — classified as 1 injury, 2 malfunctions.

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.

• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A REVISION SURGERY TO A PREVIOUSLY FUSED LUMBAR SPINE. THIS CASE IS A T12-L3 FUSION WITH EXPEDIUM AND CONCORDE BULLET (CFRP) TLIF AT T12/L1. THE CAGE WAS A CFRP CONCORDE BULLET 8MM LORDOTIC. THE SURGEON ASKED THE FELLOW TO ADJUST THE INSERTER LATERALLY AS HE ADVANCED THE CAGE TO GET THE CAGE TO THE DESIRED POSITION IN THE DISC SPACE. AFTER THE FIRST STRIKE WITH THE MALLET, THE FELLOW ATTEMPTED TO ADJUST TO CAGE LATERALLY. TOO MUCH FORCE WAS APPLIED AND THE CAGE BROKE. THE CAGE WAS REMOVED EASILY. ANOTHER 8MM CAGE WAS USED AND IMPLANTED SUCCESSFULLY WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A CONCORDE CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10747509 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING LUMBAR REVISION SURGERY, THE DEVICE WAS BROKEN. PRIOR TO INSTRUMENTATION WAS L3-5 WITH EXPEDIUM. THIS REVISION SURGERY WAS TO EXTEND THE CONSTRUCT TO L2-5 AND PERFORM A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2/3. THE RODS AND SET SCREWS WERE REMOVED FROM THE PREVIOUS CONSTRUCT BUT THE EXISTING PEDICLE SCREWS WERE NOT REMOVED. NEW PEDICLE SCREWS WERE PLACED AT L2 UNDER NAVIGATION WITH MEDTRONIC STEALTH. THE DISCECTOMY WAS PERFORMED, AND THE ENDPLATES OF L2/3 WERE PREPARED. THE INTERBODY FUSION DEVICE WAS TO BE A CONCORDE BULLET (9W X 8H X 23L - 1878-23-408). THE SHAVERS AND AN 8MM TRIAL WERE USED. THE CAGE WAS INSERTED INTO THE DISC SPACE WITH MODERATE TO LIGHT RESISTANCE USING THE CONCORDE INSERTER. THE FINAL POSITION OUGHT TO BE SLIGHTLY ANTERIOR AS THE MOST DISTAL TANTELUM MARKERS WERE IN LINE WITH THE ANTERIOR BORDER OF THE VERTEBRAE. THE CAGE WAS PULLED BACK AND BROKE WITH THE INSERTER ATTACHED. DURING BREAKAGE OF THE CAGE THERE WAS NOT EXCESSIVE FORCE EXERTED, BUT A "POP" WAS HEARD. THE INSTRUMENT WAS CAUTIOUSLY REMOVED FROM THE DISC SPACE AND THE BREAKAGE WAS DISCOVERED. THE CAGE BROKE INTO TWO PIECES; THERE WERE NO SMALL

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10650194 ↗
• MalfunctionAug 17, 2017Break; Break

  IMPLANT BECAME DISCONNECTED FROM IMPLANT HOLDER AND SHATTERED DURING INSERTION INTO PATIENT. THIS LAY IN SITU AND WAS REMOVED BEFORE THE PROCEDURE CONTINUED. ANOTHER CAGE WAS THEN SUCCESSFULLY INSERTED INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802077 ↗