BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE

    MDR report key: 2981345 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-01212
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    July 25, 2011
    Manufacturer
    SYNTHES
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT 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.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS NOTED THAT THIS COMPLAINT (B)(4), MFR REPORT #2520274-2013-01212 IS A DUPLICATE FILING FOR COMPLAINT (B)(4), MFR REPORT #2520274-2013-01197. SYNTHES USA IS RETRACTING MFR REPORT #2520274-2013-01212. MFR REPORT #2520274-2013-01197 WILL REMAIN ON FILE.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    PATIENT 2, IT WAS REPORTED THAT THE SPACER HAS MOVED. THIS IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84491 SPINE HSB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1