BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PL-20 HOLES

    MDR report key: 14623214 · Received June 7, 2022

    Report

    Report Number
    2939274-2022-02121
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 12, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10887587054964
    PMA / PMN Number
    K010943
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: HRS AND JDQ. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE SAFETY PIN BACKED OUT OF STERNAL PLATE AFTER IT WAS IMPLANTED. THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STRAIGHT PL-20 HOLES THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141375 TI STERNAL LOCKING STRAIGHT PL-20 HOLES SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 460.023 10887587054964

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention