BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM

    MDR report key: 7501970 · Received May 10, 2018

    Report

    Report Number
    2939274-2018-52111
    Event Type
    Injury
    Date Received
    May 10, 2018
    Report Date
    April 19, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982176462
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT IS UNKNOWN. ADDITIONAL PRODUCT CODE: JDQ. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 A PATIENT UNDERWENT REMOVAL OF ONE (1) DYNAMIC HIP SCREW (DHS) / DYNAMIC CONDYLAR SCREW (DCS) ONE-STEP LAG SCREW, ONE (1) 130 DEGREE DHS PLATE-STANDARD BARREL 2-HOLES/46 MM, AND ONE (1) UNKNOWN TRAUMA CORTEX SCREW ON (B)(6) 2018 DUE TO RETURN OF BENIGN NEOPLASM (TUMOR) AND SUSPECTED INFECTION. THE CONSTRUCT WAS INITIALLY IMPLANTED ON (B)(6) 2018. THE REMOVAL PROCEDURE INCLUDED USE OF A CEMENT SPACER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PATIENT OUTCOME REPORTED AS OK. THIS REPORT IS FOR A 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46 MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344552 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM APPLIANCE, FIXATION, NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 281.021 H448407 10886982176462

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention