BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15MM TOGGLELOC TM W/ PE CL

    MDR report key: 4210437 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08335
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK083070
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014- 08273 / 08334 / 08335 / 08336).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL REPAIR PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, A WASHOUT AND DRAINAGE OF THE WOUND WAS PERFORMED ON (B)(6) 2014 DUE TO AN INFECTION CAUSED BY A TYPE OF STAPHYLOCOCCUS BACTERIA (STAPH INFECTION). THERE WERE NO COMPONENTS REMOVED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691687 15MM TOGGLELOC TM W/ PE CL FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 475320

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R