BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2780563 · Received October 5, 2012

    Report

    Report Number
    2246640-2012-00023
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 11, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K081227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS COMPLETED USING THE INFO PROVIDED BY THE INITIAL REPORTED/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED. MFG RECORDS FOR THE SUBJECT LOT OF PRODUCT WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE MFR FOR THE SUBJECT LOT. THERE HAVE NO ADD'L COMPLAINTS OF THIS NATURE INVOLVING ANY OTHER UNITS MANUFACTURED FROM THIS LOT OF PRODUCT, AND NO TRENDS IDENTIFIED. BASED ON THE LIMITED INFO PROVIDED, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT AND ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED RESORBABLE BONE VOID FILLER FOLLOWING A DISTAL RADIUS FRACTURE, AND DEVELOPED SIGNIFICANT POST-OP SWELLING AT THE SITE. THE SURGEON STATED HE WAS UNSURE IF THE SWELLING WAS THE RESULT OF THE FRACTURE, THE PROCEDURE OR THE GRAFT MATERIAL. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADD'L PT INFO FROM THE SURGEON, HOWEVER NONE WAS PROVIDED. IT IS UNK IF ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. OTSCT1102020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other