BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTI CONCORDE

    MDR report key: 20185253 · Received September 10, 2024

    Report

    Report Number
    3012966183-2024-00012
    Event Type
    Injury
    Date Received
    September 10, 2024
    Report Date
    September 10, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K180590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER THAN THE TIMEFRAME OF STUDY FALLING BETWEEN 2017 AND 2019, NO FURTHER ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED BY THE COMPLAINANT. NO SPECIFIED DEVICE PART NUMBER, LOT NUMBER, UDI, OR METRICS WERE PROVIDED. NO PATIENT OR FACILITY CAN BE IDENTIFIED AS THE EVENT AND DEVICES WERE REPORTED AS AN OUTPUT FROM THE CUSTOMER'S CLINICAL EVALUATION REPORT CONDUCTED FOR A RETROSPECTIVE STUDY. NO ADDITIONAL FINDINGS AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED EVENTS RELATED TO A CLINICAL EVALUATION REPORT DERIVED FROM RETROSPECTIVE STUDIES BETWEEN 2017 AND 2019. CUSTOMER DESCRIBED EVENTS AS FOLLOWS: THIS IP CAPTURE THE FOLLOWING EVENTS AT 12 MONTHS: (N=2) REVISION. (N=1) PSEUDOARTHROSIS. (N=3) HARDWARE FAILURE. THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING 3D PRINTED TITANIUM BANANA INTERBODY CAGES VERSUS TITANIUM-COATED PEEK BULLET CAGES FOR TLIF. REPORTED COMPLICATIONS INCLUDE THE FOLLOWING: CONDUIT TLIF SYSTEM 12 MONTHS 9 LEVELS HAD SUBSIDENCE (N=3) PSEUDOARTHROSIS (N=1) ADJACENT SEGMENT DISEASE 24 MONTHS (N=1) REVISION (N=2) PSEUDOARTHROSIS (N=1) HARDWARE FAILURE (N=2) ADJACENT SEGMENT DISEASE PROTI PEEK BULLET CAGE 12 MONTHS 14 LEVELS HAD SUBSIDENCE (N=2) REVISION (N=1) PSEUDOARTHROSIS (N=3) HARDWARE FAILURE 24 MONTHS (N=4) HARDWARE FAILURE (N=2) ADJACENT SEGMENT DISEASE THIS IS FOR DEPUY SYNTHES CONDUIT TLIF SYSTEM AND PROTI PEEK BULLET CAGE. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330513 PROTI CONCORDE INTERBODY SPACER MAX TYBER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other