BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA GUARD L F/EPD+APD NO. 05.001.059

    MDR report key: 3221045 · Received July 11, 2013

    Report

    Report Number
    8030965-2013-04285
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 5, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AND IT INDICATES THAT THE DEVICE TIP IS BROKEN OFF. THE DEVICE WAS ANALYZED FOR CONFORMANCE. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE MEASURABLE DIMENSIONS WERE CHECKED AND IT WAS FOUND TO BE IN COMPLIANCE. THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE IS UNKNOWN. TOO MUCH MECHANICAL FORCE APPLIED DURING THE SURGERY COULD HAVE CONTRIBUTED TO THIS COMPLAINT . NO PRODUCT FAULT COULD BE DETECTED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DEVICE BROKE DURING A CRANIOTOMY ON (B)(6) 2013. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320303 DURA GUARD L F/EPD+APD NO. 05.001.059 HWE SYNTHES GMBH 8063086

    Patients

    Seq Age Sex Outcome Treatment
    1