CONCORDE 196923011Recalls & reported problems
Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL CAGE 9 x 11 x 23mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034454498), received between Apr 2, 2018 and Apr 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
Device problems
- Migration or Expulsion of Device1
Patient problems
- Not Applicable1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
DOCTOR'S PA INFORMED ME THAT THEY HAD A PATIENT WE HAD DONE A TLIF ON AT METHODIST HOSPITAL FOR SURGERY ON (B)(6) 2018. WHILE SHE WAS PULLING UP IMAGES TO SHOW ME SHE EXPLAINED TO ME THAT THE PATIENT WAS PRESENTING WITH POST OP PAIN. SHE STATED THAT THE PATIENT HAD BEEN AWAKENED BY A FAMILY MEMBER THE DAY AFTER SURGERY AND WAS STARTLED, CAUSING HER TO LEAP FROM THE BED. SHE BEGAN TO PRESENT WITH PAIN, SO THEY ORDERED A NEW MRI. WE FIRST LOOKED AT THE MRI WHICH APPEARED TO SHOW THE PATIENT¿S HARDWARE IN GOOD POSITION WITH NO INTERBODY MIGRATION AND THE SCREWS APPEARED TO BE IN A GOOD POSITION. AFTER REVIEWING THE MRI, THE PA PULLED UP XRAYS WHICH HAD BEEN TAKEN SEVERAL DAYS AFTER THE POSTOP MRI BECAUSE THE PATIENT¿S PAIN HAD BEEN INTENSIFYING. THE XRAYS REVEALED THAT A CAP HAD COME OFF AND THE CONCORDE BULLET TI GRAFT WHICH HAD BEEN IN GOOD POSITION HAD PARTIALLY EXTRUDED AND HAD SETTLED WITH A PORTION OF THE GRAFT IN THE FORAMEN. I DISCUSSED WHAT I SAW WITH THE PA AND SHE SAID THAT I WOULD NEED TO DISCUSS THE SITUATION WITH DOCTOR. WHEN HE LOOKED AT THE IMAGING WITH ME; HE DETERMINED THAT A REVISION SURGERY NEEDED TO BE DONE. HE INSTRUCTED THE PATIENT TO COME TO THE ER AND THAT A R
Patient problems: Not Applicable; Pain
MAUDE report 7390090 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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