BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEED 11 X 10 X 10MM IMPLANT

    MDR report key: 6273443 · Received January 24, 2017

    Report

    Report Number
    1649263-2017-10001
    Event Type
    Injury
    Date Received
    January 24, 2017
    Report Date
    January 3, 2017
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    PMA / PMN Number
    K142292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN PART NUMBER PROVIDED. BASED ON PRODUCT DESCRIPTION PROVIDED, PART NUMBER WAS DETERMINED TO BE SE-1110. (B)(4). DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: BRAND NAME, COMMON DEVICE NAME, MFR NAME,CITY, AND STATE, MODEL #/LOT #, PMA# ¿ 510K: THIS REPORT IS FOR AN UNKNOWN 10X11X10 BME STAPLE/UNKNOWN LOT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REPORTED THAT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WAS PERFORMED WHERE THE SURGEON WAS USING A 10 X 11 X 10 STAPLE. TO USE THE STAPLE, IT REQUIRES THAT IT BE PUSHED IN THEN THE TAB PUSHED FORWARD THROUGH THE HOLDER. THE SURGEON WAS NOT AWARE OF THIS AS NO ONE HAD INSTRUCTED HIM; THEREFORE, HE THOUGHT IT WAS A TWIST OFF, WHICH CAUSED IT TO TEAR THROUGH THE BONE. IT DIDN¿T SINK FLUSH, DISPLACED AND SURGEON HAD TO PULL OUT, RELOAD AND RE-DRILL. IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. IT WAS NOTED THAT THE STAPLES ARE HOLDING AND THERE HAS NO LOSS OF REDUCTION SO FAR. CONCOMITANT DEVICES REPORTED: HOLDER (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56651 SPEED 11 X 10 X 10MM IMPLANT BONE STAPLE JDR BIO MEDICAL ENTERPRISES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE UNKNOWN HOLDER