BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 6710247 · Received July 13, 2017

    Report

    Report Number
    2520274-2017-11933
    Event Type
    Injury
    Date Received
    July 13, 2017
    Report Date
    June 15, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT¿S IDENTIFIER IS NOT PROVIDED FOR REPORTING. DATE OF PSEUDARTHROSIS DEVELOPMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN ANGLE PLATE. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBERS, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). REPORTER PHONE NUMBER IS NOT AVAILABLE FOR REPORTING. THE (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBER FOR PLATE IS NOT PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DEVICE HAD BEEN IMPLANTED IN THE REVISION SURGERY ON (B)(6) 2016. POSTOPERATIVELY ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT PSEUDARTHROSIS OCCURRED. THE THIRD SURGERY FOR REVISING TO THE LARGE PHP (PROXIMAL HUMERUS PLATE) WAS PERFORMED ON (B)(6) 2017. NO DELAY IN SURGERY WAS REPORTED. PATIENT OUTCOME WAS GOOD, REVISION SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT ADDRESSES SECOND REVISION SURGERY DUE TO PSEUDARTHROSIS. THE FIRST REVISION DUE TO BROKEN SCREWS HAS BEEN CAPTURED UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) UNKNOWN ANGLE PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491072 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention