BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11 GAUGE AUTOPLEXTM SYSTEM WIT

    MDR report key: 1051845 · Received May 23, 2008

    Report

    Report Number
    2648666-2008-00063
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    STRYKER PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPLEX CEMENT DELIVERY SYS WHICH WAS USED DURING THE PROCEDURE WAS NOT RETURNED TO THE MFR FOR EVAL AND THE ALLEGED CONDITION WAS UNABLE TO BE RECREATED. AT THIS TIME, NO CAUSAL LINK HAS BEEN DRAWN BETWEEN THE AUTOPLEX AND THE CEMENT LEAK INTO THE PT'S SPINAL CANAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CEMENT LEAKED INTO THE PT'S SPINAL CANAL. THE PT REPORTED LEG NUMBNESS AND PAIN AS A RESULT, THE DR DID A DECOMPRESSION AND LAMINECTOMY. THE PT WAS IN THE ICU FOLLOWING THE PROCEDURE, BUT IS NOW OUT OF THE ICU. ACCORDING TO THE DR, THE PT'S BACK PAIN IS GONE AND IS REGAINING STRENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11 GAUGE AUTOPLEXTM SYSTEM WIT CEMENT MIXING KIT JDZ STRYKER PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention