BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    MDR report key: 8631616 · Received May 22, 2019

    Report

    Report Number
    2939274-2019-58197
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Report Date
    April 23, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982146250
    PMA / PMN Number
    K131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HRS, JDS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. 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) 2019, THE PACKAGE WAS RECEIVED EMPTY. THE ONLY THING INSIDE WAS THE PACKING SLIP WHICH SHOWS THE IMPLANTS WERE SHIPPED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL PRODUCTS FOR THIS EVENT ARE CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A CORTEX SCREW. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427603 3.5MM CORTEX SCREW SELF-TAPPING 14MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 204.814 10886982146250

    Patients

    Seq Age Sex Outcome Treatment
    1