BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7X10MM HT X-DRIVE SCREW

    MDR report key: 3844570 · Received June 3, 2014

    Report

    Report Number
    0001032347-2014-00182
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 9, 2013
    Report Date
    May 15, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON IN THIS CASE INDICATED THE REVISION WAS DUE TO PATIENT CONDITION AND NOT AS A RESULT OF THE PRODUCT FUNCTION. THERE ARE NO INDICATIONS OF ANY MANUFACTURE DEFECT WITH THE REPORTED EXPLANTED ITEMS. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. FILE 3 OF 4.

    Description of Event or Problem · 1

    A REVISION WAS PERFORMED DUE TO PROGRESSIVE RESORPTION OF THE LEFT CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323445 2.7X10MM HT X-DRIVE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A 164420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization