BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM-STER

    MDR report key: 11901891 · Received May 28, 2021

    Report

    Report Number
    8030965-2021-04409
    Event Type
    Injury
    Date Received
    May 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    INNOMEDIC GMBH
    Product Code
    HRS
    UDI-DI
    07611819359994
    PMA / PMN Number
    K111540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT REMOVAL OF SIX (6) LOCKING SCREWS AND ONE (1) CLAVICLE PLATE DUE TO DISCOMFORT FROM MATERIAL UNDER THE SKIN. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2019. THERE WAS A THIRTY (30) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME WAS POSITIVE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM-STER. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799440 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM-STER PLATE,FIXATION,BONE HRS INNOMEDIC GMBH 07611819359994

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention