BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CORTEX

    MDR report key: 12388122 · Received August 30, 2021

    Report

    Report Number
    2939274-2021-05015
    Event Type
    Injury
    Date Received
    August 30, 2021
    Report Date
    August 24, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: CORTEX/UNKNOWN LOT. PART AND LOT NUMBERS 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. 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 FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING LCP SUPERIOR CLAVICLE PLATE. DBM 5CC WAS USED AS AN ADDITIONAL SURGICAL INTERVENTION. A REOPERATION WAS DONE DUE TO HARDWARE REMOVAL, PATIENT COULD FEEL IMPLANT. UNION WAS ACHIEVED AFTER 8 WEEKS. NO POST-OPERATIVE COMPLICATIONS REPORTED. CONCOMITANT DEVICES REPORTED: UNK: SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 4). THIS REPORT IS FOR (1) UNK, SCREWS: CORTEX. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285886 UNK - SCREWS: CORTEX SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 3.5 LCP SUP CLAV PL LAT EXTN/7H/LT/120| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX