BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 8905840 · Received August 19, 2019

    Report

    Report Number
    2939274-2019-59884
    Event Type
    Injury
    Date Received
    August 19, 2019
    Report Date
    July 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (B)(4). 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) 2017, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO SURGICAL WOUND DEHISCENCE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH MEDIAL COLUMN FUSION PLATE SYSTEM DURING SURGERY OF PRIMARY MEDIAL COLUMN ARTHRODESIS OF TNJ, NCJ, AND FIRST TARSO-METATARSAL JOINT (TMTJ) ON (B)(6) 2016. POST-OPERATIVELY, THE PATIENT HAD NONUNION AND SURGICAL WOUND DEHISCENCE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700134 UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention