BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE GRAFTING MATERIAL, SYNTHETIC

    MDR report key: 6724323 · Received July 19, 2017

    Report

    Report Number
    2520274-2017-11944
    Event Type
    Injury
    Date Received
    July 19, 2017
    Report Date
    June 21, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE ¿XXX¿ USED AS THE CODE APPLICABLE TO ¿ BONE GRAFTING MATERIAL, SYNTHETIC¿ WAS NOT AVAILABLE FOR SELECTION. THE ACTUAL DEVICE CODE IS ¿LYC¿. THIS REPORT IS FOR UNKNOWN CHRONOS GRANULES. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR CHRONOS GRANULES IS NOT PROVIDED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT RECENTLY UNDERWENT A PROCEDURE WHERE CHRONOS GRANULES WERE PLACED ON THE TEMPORAL LOBE AREA OF THE HEAD AND THE PATIENT IS NOW EXPERIENCING EXTREME PAIN AND OTHER COMPLICATIONS. THIS REPORT IS FOR UNKNOWN CHRONOS GRANULES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507078 BONE GRAFTING MATERIAL, SYNTHETIC LYC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention