BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 34MM

    MDR report key: 12623903 · Received October 13, 2021

    Report

    Report Number
    2939274-2021-06038
    Event Type
    Injury
    Date Received
    October 13, 2021
    Report Date
    September 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982144836
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: DZL, KTW. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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) 2021, THREE (3) PELVIC SCREWS AND FOUR (4) CORTEX SCREWS WERE REMOVED FROM THE PATIENT FOR AN UNKNOWN REASON. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2017. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 34MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519604 2.7MM CORTEX SCREW SELF-TAPPING 34MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 202.834 10886982144836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX