CONCORDE 196927519Recalls & reported problems
Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM LORDOTIC CAGE 9 x 9 x 27mm · 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 10705034454412), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2019Migration; Migration
THE FOLLOWING WAS REPORTED: DATE J&J BECAME AWARE: (B)(4) 2019. DATE OF EVENT: (B)(6) 2019. NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON: MR (B)(6). HOSPITAL TOWN: (B)(6). PRODUCT NAME: CONCORDE TITANIUM CAGE (9X9X27MM, LORDOTIC). PRODUCT CODE: 196927519. LOT/BATCH/EXP: 511996. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? THE CAGE WAS REMOVED AND A NEW LARGER CAGE INSERTED (196927511). WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? PROVIDED ITS RETURNED FROM CSSD. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: MR (B)(6) HAD PERFORMED A PREVIOUS L4/5 TLIF WITH CONCORDE TI AND EXPEDIUM VERSE. A FEW MONTHS POST OP THE PATIENT RETURNED TO THE HOSPITAL AFTER SENSING A POPPING SENSATION IN THEIR BACK ON ACTIVITY. X RAYS SHOWED THAT THE IMPLANT HAD BEGUN TO BACK OUT- THE REASON FOR THE REVISION SURGERY. MR (B)(6) REVISED THE CAGE INSERTING ANOTHER TITANIUM CONCORDE SI
Patient problems: No Code Available
MAUDE report 8363273 ↗
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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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