BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

    MDR report key: 3182675 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03634
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PLANNED IMPLANT REMOVAL SURGERY, THE HEAD OF 3 SCREWS BROKE OFF DURING THE REMOVAL PROCESS. THE SURGEON CHOSE NOT TO REMOVE THE REMAINING SCREWS AND THEY WERE LEFT IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283983 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention