BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 8MM HEIGHT

    MDR report key: 2120322 · Received June 2, 2011

    Report

    Report Number
    1719045-2011-00272
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 23, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. DEVICE NOT EXPLANTED AT THIS TIME, SURGEON IS SCHEDULING. UNABLE TO PROVIDE THE DATE OF MFR AS NO DEVICE WAS RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    ASYMPTOMATIC PT RETURNED TO SURGEON FOR OFFICE VISIT. AN X-RAY SHOWED ONE SCREW BACKING OUT OF THE ZERO-P IMPLANT, LEVEL UNK. SURGEON NOTED THE IMPLANT WAS IN GOOD POSITION. SURGEON IS SCHEDULING A REVISION TO REMOVE PRODUCT. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P IMPLANT 8MM HEIGHT ZERO-P IMPLANT ODP SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREW