BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO BURR HOLE COVER24MM

    MDR report key: 5183381 · Received October 28, 2015

    Report

    Report Number
    2520274-2015-16874
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    August 7, 2015
    Report Date
    October 13, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BRAND NAME. TI MATRIXNEURO BURR HOLE COVER 24MM. COMMON NAME: BONE PLATE. IMPLANT AND EXPLANT DATES: UNKNOWN. THE SUBJECT DEVICE HAS BEEN REQUESTED FOR RETURN TO MANUFACTURER FOR EVALUATION BUT HAS NOT BEEN RECEIVED. INITIAL REPORTER FACILITY NAME IS: (B)(6). (B)(4). PMA 510(K): K042365. 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

    SYNTHES COMPLAINT HANDLING UNIT (CHU) RECEIVED A MAUDE EVENT REPORT FOR UF/IMPORTER REPORT # (B)(4) ON (B)(6) 2015. IT WAS REPORTED THAT TI MATRIXNEURO BURR HOLE COVER 24MM PLATES BROKE AND AN ADDITIONAL CRANIOTOMY WAS PERFORMED TO ATTACH NEW PLATES TO THE BONE FLAP TO SECURE IT. ADDITIONAL EVENT AND PATIENT INFORMATION HAVE BEEN REQUESTED BUT A RESPONSE HAS NOT BEEN RECEIVED BEFORE THE SUBMISSION OF THIS REPORT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715913 TI MATRIXNEURO BURR HOLE COVER24MM BONE PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention