BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPLATE TITANIUM FIXATION SYSTEM

    MDR report key: 1660953 · Received April 14, 2010

    Report

    Report Number
    2029447-2010-00003
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BIOPLATE
    Product Code
    JEY
    PMA / PMN Number
    K082757
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOPLATE WAS INFORMED BY (B) (4) IN-COUNTRY REP OF THIS INCIDENT ON APRIL 13, 2010. IT WAS DETERMINED THAT THIS PRODUCT WAS PART OF THE CURRENT RECALLED LOTS (PRODUCT CODE 81-3591, LOT# G03560209). NO FURTHER INFO HAS BEEN PROVIDED BY THE DISTRIBUTOR OR THE HOSP. (B) (4) DISTRIBUTOR WAS NOTIFIED OF RECALL ON MARCH 22, 2010. IT IS UNK IF THE HOSP WAS NOTIFIED OF THE RECALL PRIOR TO INITIAL SURGERY THAT TOOK PLACE ON (B) (6) 2010. OTHER SURGERIES WERE ALSO PERFORMED THAT WEEK UTILIZING THE SAME PRODUCT CODE AND LOT NUMBER AND NO ADVERSE EFFECTS WERE REPORTED. CURRENTLY AWAITING ADD'L INFO FROM (B) (4) DISTRIBUTOR AS TO WHEN THIS HOSP WAS NOTIFIED OF THE RECALL.

    Description of Event or Problem · 1

    ON MEETING WITH STAND-IN FOR FULL TIME NUM, ON FRIDAY (B) (4), TO FOLLOW PRODUCT RECALL 81-3591 TO ENSURE THE HOSP HAD ADEQUATE SUPPLY OF PRODUCT OVER THE WEEKEND, AFTER DISCUSSION, IT WAS FOUND THAT A PT WAS BEING RETURNED TO THE THEATRE THAT EVENING WITH A CRANIAL INFECTION. ON CHECKING THE PROSTHESIS BOOK, IT WAS FOUND THAT THE PT HAD BIOPLATE 81-3591 LOT NUMBER G03560209 IMPLANTED ON (B) (6) 2010. THE DIRECTOR OF NURSING WAS INFORMED OF THE SITUATION AND INFECTION CONTROL ADVISED. THE HOSP THEN NOTED ALL PTS WHOM HAD BIOPLATE 81-3591 LOT NUMBER G03560209 IMPLANTED AND FOUND THAT THE SAME LOT NUMBER HAD BEEN IMPLANTED IN VARIOUS PTS THAT SAME WEEK. I OFFERED TO COME INTO THE THEATRE THAT EVENING TO SUPPORT THE SURGEON, HOWEVER, THE HOSP REQUESTED FOR PRIVACY REASONS, I DID NOT ATTEND THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLATE TITANIUM FIXATION SYSTEM BONE FIXATION PLATES AND BONE SCREWS JEY BIOPLATE 81-3591 G03560209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention