BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVER, BURR HOLE

    MDR report key: 5764803 · Received July 1, 2016

    Report

    Report Number
    2520274-2016-13340
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 13, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    GXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN CLAMP. BASED INFORMATION FROM A RELATED COMPLAINT (B)(4) SUBMITTED ON THE SAME DEVICE REPORT, THIS CLAMP MAY BE PART NUMBER 851.801.01S, RAPID RESORBABLE CRANIAL CLAMP 18MM, LOT UNKNOWN, DEVICE PRODUCT CODES HBW AND GXR, COMMON NAME¿COVER, BURR HOLE, 510(K) K041611. ADDITION INQUIRY WAS MADE IN AN ATTEMPT TO IDENTIFY THE PART NUMBER OF THE COMPLAINED DEVICE BUT A RESPONSE HAS NOT BEEN RECEIVED. AS OF THE SUBMISSION DATE OF THIS REPORT, THIS DEVICE IS CONSIDERED UNKNOWN. THE COMPLAINED DEVICE WAS NOT IMPLANTED. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION AND HAS BEEN DISCARDED BY THE REPORTING FACILITY. 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. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2016 THE UNKNOWN CLAMP BROKE WHEN IT WAS TIGHTENED. ANOTHER CLAMP WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421023 COVER, BURR HOLE GXR SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1