BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG

    MDR report key: 10984425 · Received December 10, 2020

    Report

    Report Number
    2939274-2020-05534
    Event Type
    Injury
    Date Received
    December 10, 2020
    Report Date
    November 16, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982037008
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HISTORY LOT: PART: 02.117.604, LOT: 9031164, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 23. JUNE 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS IS REPORT 3 OF 6 FOR (B)(4). THIS (B)(4) CAPTURES THE INFECTION POSTOPERATIVELY WHILE THIS (B)(4) CAPTURES THE SCREWS THAT BROKE DURING REMOVAL INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452336 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.117.604 9031164 10886982037008

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention 3.5MM LCP HOOK PLATE 3 HOLE| UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING| UNK - SCREWS: TRAUMA