BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM

    MDR report key: 4181424 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14189
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRS. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS TREATED FOR FEMORAL NECK FRACTURE AND WAS IMPLANTED WITH A DYNAMIC HIP SYSTEM (DHS) 4 HOLE PLATE. THE PATIENT PRESENTED TO THE OFFICE FOR FOLLOW UP WITH A COLLAPSED NECK AND FAILURE TO HEAL/NON-UNION WHICH WAS VISUALIZED VIA X-RAY. THE SURGEON PLANS TO REMOVE PLATE ON (B)(6) 2014 AND DO A TOTAL HIP REPLACEMENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 DUE TO PATIENT PAIN/DISCOMFORT AND A FEMORAL NECK COLLAPSE AT THE ORIGINAL FRACTURE SITE. THERE WAS NO DEVICE ALLEGATION AGAINST ANY OF THE HARDWARE; ALL HARDWARE WAS REMOVED INTACT AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED SUCCESSFULLY. THIS IS REPORT NUMBER 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661032 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM APPLIANCE,FIXATION,NAIL KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention