BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM

    MDR report key: 12455343 · Received September 10, 2021

    Report

    Report Number
    2939274-2021-05316
    Event Type
    Injury
    Date Received
    September 10, 2021
    Report Date
    August 13, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982032638
    PMA / PMN Number
    K111540
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. THE 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION SURGERY FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER12 WEEKS DURATION AND REPORTED POST-OPERATIVE COMPLICATION WAS PROLONGED PAIN . PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 10). THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1)3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM. THIS REPORT IS 1 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353711 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.112.010 10886982032638

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX