BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2896649 · Received January 4, 2013

    Report

    Report Number
    2520274-2013-00066
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DURING A DHS HIP SCREW PROCEDURE, THE SCREW HEAD SHEARED OFF. THE SCREW AND PLATE WAS IMPLANTED AS THE SURGEON WAS FINAL TIGHTENING, THE SCREW HEAD SHEARED OFF. THE HEAD OF THE SCREW WAS RETRIEVED FROM THE WOUND. AN X-RAY WAS TAKEN TO ENSURE THERE WERE NO FRAGMENTS IN THE PATIENT. THE REMAINDER OF THE SCREW IS STILL IMPLANTED IN THE PATIENT BONE. THE SURGEON DID NOT ATTEMPT TO REMOVE THE SCREW AND REPLACE IT. THE SURGEON PLACED CERCLAGE WIRE AROUND THE AREA WITH THE BROKEN SCREW HEAD TO REINFORCE THE IMPLANT. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4172 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention SCREW