BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM

    MDR report key: 12456498 · Received September 10, 2021

    Report

    Report Number
    2939274-2021-05336
    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
    10886982032577
    PMA / PMN Number
    K111540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. 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 FOR A FRACTURE REMOVAL SURGERY FOR A SHAFT FRACTURE UTILIZING AN LCP SUPERIOR-ANTERIOR CLAVICLE PLATE. THERE WAS A UNION OF FRACTURE AFTER 12 WEEKS DURATION. 1 YEAR POSTOPERATIVELY, HARDWARE REMOVAL WAS REPORTED DUE TO PATIENT COULD FEEL THE IMPLANT. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 6). THIS COMPLAINT INVOLVES SEVEN(7) DEVICES. THIS REPORT IS FOR (1)3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350226 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.112.007 10886982032577

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention