BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL-FREE CROSS-DRIVE MINI SCREW

    MDR report key: 1812651 · Received August 17, 2010

    Report

    Report Number
    9610905-2010-00015
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    KARL LEIBINGER GMBH U. CO. KG
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF PRODUCT FROM FACILITY. ONCE RECEIVED, IT WILL BE SENT TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DOCTOR WAS PERFORMING A SURGERY WHEN THE HEAD OF THE SCREW BROKE OFF. PT'S HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL-FREE CROSS-DRIVE MINI SCREW MINI-SCREW DZL KARL LEIBINGER GMBH U. CO. KG 25-679-05-1 30745734

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other