BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 2001716 · Received February 25, 2011

    Report

    Report Number
    1030489-2011-00208
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQV
    PMA / PMN Number
    K060794
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A NO. 5 TOOTH EXTRACTION WITH PLACEMENT OF AN IMPLANT IN THE OSTEOTOMY SITE. AN UNKNOWN TIME POST-OP, THE PATIENT REPORTED SENSITIVITY TO PRESSURE. THE IMPLANT FAILED TO INTERGRATE AND WAS EXPLANTED APPROXIMATELY THREE MONTHS LATER. THE AREA WAS REGRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY FILLER, BONE VOID, CALCIUM COMPOUND MQV MEDTRONIC SOFAMOR DANEK 1402250017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention