BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    AUTOPLEX SYSTEM W/ VERTAPLEX HVV

    MDR report key: 15107792 · Received July 26, 2022

    Report

    Report Number
    3015967359-2022-01519
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    June 30, 2022
    Report Date
    October 24, 2022
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    JDZ
    UDI-DI
    37613252039250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE 1 PREVIOUSLY REPORTED EVENT IS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE.1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355829 AUTOPLEX SYSTEM W/ VERTAPLEX HVV MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VMSR 37613252039250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown