BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 10711860 · Received October 21, 2020

    Report

    Report Number
    2939274-2020-04749
    Event Type
    Injury
    Date Received
    October 21, 2020
    Report Date
    September 28, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982154644
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1). 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176218 4.5MM CORTEX SCREW SELF-TAPPING 30MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 214.830 10886982154644

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention