BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3133091 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02928
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDO
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH ZIPFIX ON (B)(6) 2013. DURING A FOLLOW-UP EXAM ON (B)(6) 2013 IT WAS NOTED ONE ZIPFIX HAD NOT LOCKED AND WAS LOOSE. THE ZIPFIX PROTRUDED THROUGH THE SKIN CAUSING THE PATIENT PAIN, IRRITATION AND DISCOMFORT. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF THE LOOSE ZIPFIX. THE PATIENT WAS NOT REVISED AND WENT ON TO HEAL NORMALLY. THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236263 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention