BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5131500 · Received October 7, 2015

    Report

    Report Number
    2520274-2015-16464
    Event Type
    Injury
    Date Received
    October 7, 2015
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). TWO PLATE NUMBERS WERE REPORTED FOR THIS COMPLAINT; HOWEVER, IT IS UNKNOWN WHICH PLATE OR PLATE(S) IS/ARE ASSOCIATED WITH THE REPORTED BROKEN SCREWS. THE REPORTED PRODUCT NUMBERS ARE 02.211.203 (INITIALLY REPORTED AS 02.227.202) 2.4/2.7MM VA-LOCKING X-PLATE SMALL AND 02.211.203 2.4/2.7MM VA-LOCKING X-PLATE MEDIUM 510(K) FOR BOTH--K100776, DEVICE PRODUCT CODES AND COMMON NAMES FOR BOTH HRS PLATE, FIXATION, BONE, ADDITIONAL DEVICE PRODUCT CODE HWC. (B)(4) ADDITIONAL X-RAYS AND OTHER UNKNOWN TREATMENT TO ADDRESS BROKEN SCREWS. ALTHOUGH THERE IS NO ALLEGATION OF COMPLAINT AGAINST THE PLATE, IT CANNOT BE DISASSOCIATED FROM THE COMPLAINT EVENT AT THIS TIME. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORT THAT X-RAYS TAKEN ON (B)(6) 2015 REVEALED TWO BROKEN UNKNOWN 2.4MM SCREWS AT THE FIRST METATARSAL JOINT FUSION (RIGHT SIDE). THE PATIENT INITIALLY WAS IMPLANTED WITH TWO, 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATES AND NINE SCREWS ON (B)(6) 2014. IT IS UNKNOWN WHICH OF THE REPORTED PLATES IS ASSOCIATED WITH THE BROKEN SCREWS. ANTICIPATED TREATMENT AND ADDITIONAL DETAILS ARE ALSO CURRENTLY UNKNOWN. THIS REPORT IS FOR TWO, UNKNOWN 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662397 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR