BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 16MM

    MDR report key: 11709178 · Received April 22, 2021

    Report

    Report Number
    2939274-2021-02024
    Event Type
    Injury
    Date Received
    April 22, 2021
    Report Date
    March 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZL
    UDI-DI
    10886982144744
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: HWC KTW. 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE SURGERY, FOUR (4) 2.7MM CORTEX SCREW SELF-TAPPING 16MM, TWO (2) 2.7MM CORTEX SCREW-TAPPING 18MM AND ONE (1) 2.7MM LC-DCP PLATE 6 HOLES WERE REMOVED DUE TO PAIN. NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 16MM. THIS REPORT IS 6 OF 7 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605480 2.7MM CORTEX SCREW SELF-TAPPING 16MM SCREW FIXATION INTRAOSSEOUS DZL WRIGHTS LANE SYNTHES USA PRODUCTS LLC 202.816 10886982144744

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention 2.7MM CORTEX SCREW SELF-TAPPING 16MM| 2.7MM CORTEX SCREW SELF-TAPPING 18MM| 2.7MM CORTEX SCREW SELF-TAPPING 18MM| 2.7MM LC-DCP PLATE 6 HOLES/59MM