BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM

    MDR report key: 8649504 · Received May 29, 2019

    Report

    Report Number
    2939274-2019-58356
    Event Type
    Injury
    Date Received
    May 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982175236
    PMA / PMN Number
    K964259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: JDO. IMPLANTED IN (B)(6) 2018; EXACT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER PROVIDED IS NOT VALID . 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 THE PATIENT UNDERWENT A HARDWARE REMOVAL OF DYNAMIC HIP SCREW (DHS) IMPLANT CONSTRUCTS FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019 AS THAT ENDED UP NOT HEALING. SURGEON TOOK OUT THE HARDWARE AND REVISED PATIENT TO TOTAL HIP ARTHROPLASTY. DHS WAS REMOVED WITH NO ISSUES. ORIGINAL IMPLANT DATE WAS (B)(6) 2018. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) DHS/DCS ONE STEP LAG SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443459 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 280.305 863934 10886982175236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention