BEUDAMED
    FDA Adverse Event Summary report: N

    POLYMER FASTENERS

    MDR report key: 350537 · Received September 7, 2001

    Report

    Report Number
    1221934-2001-00046
    Date Received
    September 7, 2001
    Date of Event
    May 18, 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 PATIENT DEVELOPED STAPH INFECTION WHICH WERE TREATED WITH ANTIBIOTICS BUT DID NOT CLEAR UP. THE GRAFT NEEDED TO BE REMOVED. THE IMPLANT SLID OUT OF THE KNEE WHEN A TIBIAL INCISION WAS MADE SINCE THE INFECTION HAD TURNED THE GRAFT AND BONE SOFT. 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
    40534 POLYMER FASTENERS 30MM INTRAFIX TIBIAL SHEATH MBI INNOVASIVE DEVICES 254601 0103073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PRODUCT NUMBER 254609 LOT NUMBER 0102092