BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDFOOT FUSION PLATE SMALL

    MDR report key: 4153378 · Received October 8, 2014

    Report

    Report Number
    0001825034-2014-08015
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 26, 2014
    Report Date
    December 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK093474
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. LOT NUMBER CONFIRMED TO BE DPJCBW. THE REVIEW OF THE DEVIATION HISTORY INDICATES NO ABNORMALITIES. A REQUEST FOR THE DEVICE HISTORY RECORDS HAS BEEN SUBMITTED AND A FOLLOW UP MDR WILL BE SENT WHEN THE INFORMATION IS RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE SURGICAL TECHNIQUE GUIDE THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿ALLERGIES AND OTHER ADVERSE REACTIONS TO THE DEVICE MATERIAL.¿ THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2014-08015 / 0001825034-2014-08016 / 0001825034-2014-08017).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MIDFOOT FUSION PROCEDURE ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2014 DUE TO AN ALLEGED ALLERGIC REACTION TO THE METAL IN THE IMPLANTS. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630550 MIDFOOT FUSION PLATE SMALL PLATE, FIXATION, BONE HRS BIOMET ORTHOPEDICS N/A DPJCBW

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R