BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    MDR report key: 6075784 · Received November 3, 2016

    Report

    Report Number
    2520274-2016-15192
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN (B)(6) BONE FILLER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED IN 2005 A PATIENT UNDERWENT SURGERY TO HAVE AN ACOUSTIC NEUROMA REMOVED FROM HER SEVENTH AUDITORY NERVE. (B)(6) BONE FILLER WAS USED ALONG WITH A NON-SYNTHES TITANIUM MESH. IN 2007, THE MESH HAD TO BE REMOVED DUE TO SEVERE ALLERGIC REACTION. NOTHING WAS PUT IN ITS PLACE. IN (B)(6) 2015 THE PATIENT SUFFERED A BLOW TO THE BACK OF THE HEAD AND IS NOW EXPERIENCING INTERMITTENT CEREBROSPINAL FLUID (CSF) LEAK. THE PATIENT IS UNABLE TO UNDERGO COMPUTED TOMOGRAPHY (CT), X-RAYS, OR MAGNETIC RESONANCE IMAGING (MRI) DUE TO ADVERSE EFFECTS FROM RADIATION. THE PATIENT IS TRYING TO FIGURE OUT IF THE CSF LEAK COULD BE DUE TO THE (B)(6) PRODUCT. THIS REPORT IS FOR UNKNOWN (B)(6) BONE FILLER. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727963 FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention