BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/LT/94MM

    MDR report key: 12491376 · Received September 17, 2021

    Report

    Report Number
    2939274-2021-05549
    Event Type
    Injury
    Date Received
    September 17, 2021
    Report Date
    July 23, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982032690
    PMA / PMN Number
    K111540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN UNKNOWN DATE, THE PATIENT UNDERWENT A PROCEDURE FOR A SHAFT FRACTURE FIXATION UTILIZING LCP SUPERIOR-ANTERIOR CLAVICLE PLATE. UNION WAS ACHIEVED AFTER 12 WEEKS. CLAVICLE ABSCESS WAS OBSERVED POST-OP. REOPERATION WAS DONE DUE TO HARDWARE REMOVAL SECONDARY TO ABSCESS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/LT/94MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389588 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/LT/94MM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.112.013 10886982032690

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention UNK - SCREWS: CORTEX