BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CRANIAL FLAP TUBE CLAMP 13MM DIA

    MDR report key: 3897380 · Received June 26, 2014

    Report

    Report Number
    2520274-2014-12180
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    GXN
    PMA / PMN Number
    PK992000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE IMPLANT BROKE DURING IMPLANTATION INTO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374544 TI CRANIAL FLAP TUBE CLAMP 13MM DIA PLATE,CRANIOPLASTY,PREFORMED NONALTERABLE GXN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1