BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3212356 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04208
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. IMPLANT DATE: (B)(6) 2013. EXPLANT DATE: (B)(6) 2013.

    Description of Event or Problem · 1

    A ZIP FIX BECAME UNFASTENED, POST OPERATIVE, PUSHING OUT ON SKIN IN STERNAL-CHEST AREA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314497 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention