BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX 1.4 DB/J-LATCH CALBRTD 03.511.009

    MDR report key: 12224852 · Received July 26, 2021

    Report

    Report Number
    2939274-2021-04263
    Event Type
    Injury
    Date Received
    July 26, 2021
    Report Date
    June 28, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587014425
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HBE AND ERL. 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 ON (B)(6) 2021, THE SURGEON WAS NOTIFIED THAT HE HAD TO DO A REVISION TO RETRIEVE A DRILL BIT. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120817 MATRIX 1.4 DB/J-LATCH CALBRTD 03.511.009 DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.511.340 10887587014425

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention