BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04024

    MDR report key: 3200866 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04024
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 5 UNKNOWN LOCKING SCREWS. 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. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS FOR 5 UNKNOWN LOCKING SCREWS. PATIENT UNDERWENT SURGERY ON (B)(6) 2013 FOR THE REMOVAL OF A TIBIAL ROD AND 5, 5.0 LOCKING SCREWS (3 DISTAL AND 2 PROXIMAL). THE SURGEON OBTAINED CULTURES AND IRRIGATED THE SITE. THE HARDWARE WAS NOT REPLACED AND THERE WERE NO ISSUES REPORTED DURING THE SURGERY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301750 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention