BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER

    MDR report key: 10779064 · Received November 3, 2020

    Report

    Report Number
    8030965-2020-08515
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 8, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819309982
    PMA / PMN Number
    K111540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY FOR LEFT CLAVICLE SHAFT FRACTURE WITH THE PLATE IN QUESTION. DURING THE SURGERY, WHEN THE SURGEON SET THE PLATE, THE PLATE DID NOT FIT. THE SURGEON ATTEMPTED TO BEND THE PLATE, BUT THE PLATE BROKE IN TWO FROM THE CENTER. THE SURGEON USED ANOTHER PLATE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF ABOUT FIFTEEN (15) MINUTES. THE PATIENT WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK- BENDING INST: PLATE BENDER: TRAUMA. THIS REPORT IS FOR ONE (1) 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243132 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 07611819309982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA