BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM UNIVERSAL CONNECTOR 5.6-6.35

    MDR report key: 2110865 · Received May 23, 2011

    Report

    Report Number
    1526439-2011-00082
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Product Code
    NKB
    PMA / PMN Number
    K092626
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT AS REPORTED DID NOT RESULT IN ANY ADVERSE PT OUTCOME OR SIGNIFICANT DELAY TO THE CASE. DEVICE WAS NOT RETURNED FOR EVAL AND NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED AND AS SUCH A REVIEW OF MFG RECORDS COULD NOT BE COMPLETED. A REVIEW OF RECORDS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS CATALOG NUMBER TO DATE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM UNIVERSAL CONNECTOR 5.6-6.35 SPINAL FIXATION DEVICE NKB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1