BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7501985 · Received May 10, 2018

    Report

    Report Number
    2939274-2018-52112
    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
    10886982175182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID REPORTED AS (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 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM-STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344907 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM-STERILE APPLIANCE, FIXATION, NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 280.295S H302655 10886982175182

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention