BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15842596 · Received November 22, 2022

    Report

    Report Number
    8030965-2022-10140
    Event Type
    Injury
    Date Received
    November 22, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    10886982032577
    PMA / PMN Number
    K111540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS BROUGHT TO THE OR FOR REMOVAL OF A CLAVICLE PLATE WITH NONUNION AND REVISION WITH A TIBIAL TUBERCLE BONE GRAFT AND HOOK PLATE. ALL HARDWARE WAS INTACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758860 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM PLATE, FIXATION, BONE HRS SYNTHES GMBH 02.112.007 10886982032577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - SCREWS: 2.7 MM CORTEX| UNK - SCREWS: 2.7 MM CORTEX| UNK - SCREWS: 2.7 MM CORTEX| UNK - SCREWS: 2.7 MM LOCKING| UNK - SCREWS: 2.7 MM LOCKING| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX