BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3875216 · Received June 16, 2014

    Report

    Report Number
    2520274-2014-11918
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL NARRATIVE:(B)(4): 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.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION WHICH RECORDS THE COMPLAINT ASPECTS OF 2010 MPE RESULTS. THE PATIENT SUFFERED A MINOR SPINAL DISTAL DIAPHYSEAL EXTENSION, DUE TO A FALL FROM A LADDER ON (B)(6), 2010 AND HAD SURGERY ON (B)(6), 2010. THE SURGEON STATES THAT THE FRACTURE WAS ORIGINALLY PLACED IN A KNEE SPANNING EX FIX.THE EX-FIX AIDED IN REDUCTION DURING THE CASE A K-WIRE WAS ALSO USED. THE PROXIMAL SCREWS ANGLED UP INTO THE JOINT. THIS REPORT IS FOR ONE UNKNOWN SCREW.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352490 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1