BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYMER FASTENERS

    MDR report key: 350569 · Received September 7, 2001

    Report

    Report Number
    1221934-2001-00044
    Event Type
    Injury
    Date Received
    September 7, 2001
    Date of Event
    February 7, 2001
    Report Date
    September 7, 2001
    Manufacturer
    INNOVASIVE DEVICES
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST ACL REPAIR USING THE INTRAFIX PRODUCTS PATIENTS DEVELOPED STAPH INFECTIONS WHICH WERE TREATED WITH ANTIBIOTICS. A TOTAL OF 5 SIMILAR INCIDENTS OCCURRING BETWEEN 2000 AND 2001 WERE REPORTED BY THE SAME PHYSICIAN AT A SINGLE FACILITY. PRODUCTS AND LOT NUMBERS INVOLVED AS FOLLOWS: PRODUCT NUMBER 254601 (1 PER INCIDENT) LOTS 13249, 0005042, 0011090, 0101046, AND 0103073. PRODUCT NUMBER 254603 LOTS 13373, AND 13747. PRODUCT NUMBER 254602 LOT 0011016. PRODUCT NUMBER 254609 LOTS 0011038, AND 0102092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40936 POLYMER FASTENERS 30MM INTRAFIX TIBIAL SHEATH MBI INNOVASIVE DEVICES 254601 0011090

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PRODUCT NUMBER 254602 LOT NUMBER 0011016.