BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSION MCP PROXIMAL - PROXIMAL TRIAL

    MDR report key: 2182359 · Received July 11, 2011

    Report

    Report Number
    1651501-2011-00055
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    P000057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFO ABOUT THE EVENT. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENT REPORT WILL BE FILED IF APPROPRIATE. AN MCP 20P TRIAL WAS RETURNED. THE 20P TRIAL FRACTURED UPON IMPACTION DURING SURGERY. AN EXAMINATION OF THE COMPONENTS REVEALED THE FOLLOWING: THE 20P TRIAL FRACTURE WAS CONSISTENT WITH FRACTURES KNOWN TO RESULT FROM IMPACTING AN UNSUPPORTED HEAD, WHERE THE STEM OF THE COMPONENT OR TRIAL CANNOT BE FULLY INSERTED INTO THE MEDULLARY CANAL DUE TO AN IMPROPERLY PREPARED OBLIQUE OSTEOTOMY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MCP TRIAL COMPONENT WAS FRACTURED DURING SURGERY WHEN IT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP PROXIMAL - PROXIMAL TRIAL FINGER PRYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other