BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXDRIVE SCREW LOG213732

    MDR report key: 6112734 · Received November 15, 2016

    Report

    Report Number
    MW5066105
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 14, 2014
    Report Date
    October 17, 2017
    Manufacturer
    KLS MARTIN LP
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 10/18/2017 FOR MW5066105. I UNDERWENT AN ORTHOGNATHIC SURGERY (UPPER AND LOWER JAW SURGERY) PERFORMED BY ONE DR. (B)(6) AT (B)(6) MEDICAL CENTER. A MAXDRIVE KLS MARTIN SCREW HAS BEEN BROKEN AND THE BODY OF THE BROKEN SCREW (SCREW SHAFT) WAS PRACTICALLY CATAPULTED IN MY LEFT SINUS, NEAR THE EYE, AND LEFT IN THERE. SINCE THIS INCIDENT, I REMAINED WITH CHRONIC PAIN IN MY LEFT UPPER CHEEK AND EYE, CHRONIC PAIN IN THE LEFT SIDE OF MY MOUTH ROOF, SPORADIC NASAL BLEEDING THROUGH MY LEFT NOSTRIL, SPORADIC AND SPONTANEOUS AND UNEXPLAINED SWELLING OF MY LEFT SIDE OF THE FACE. THESE SYMPTOMS WERE ABSENT BEFORE THIS INCIDENT AND ARE DOCUMENTED IN MEDICAL RECORDS AND TESTS. DURING MY SURGERY ON (B)(6) 2014, ALL THE ORTHOGNATHIC-MAXILLOFACIAL IMPLANTS AND DEVICES WERE PROVIDED BY KLS MARTIN AND A REP OF KLS MARTIN'S REP, NAMELY ONE (B)(4), PARTICIPATED AND ASSISTED AT MY SURGERY IN THE OPERATING ROOM. SINCE (B)(6) 2014 TO DATE NEITHER THE SURGEON, NAMELY DR. (B)(6), AND THE HOSPITAL ((B)(6) MEDICAL CENTER) FULFILLED THEIR DUTY TO MANDATORY REPORT THIS INCIDENT TO FDA AND TO ME AS A PT. FOLLOWING MY DILIGENT EFFORTS AND CORRESPONDENCE WITH THE KLS MARTIN'S ATTORNEY ((B)(4)), IN FEBRUARY 2017, KLS MARTIN SUBMITTED TO FDA AN INCOMPLETE INCIDENT REPORT, NAMELY MDR #9610905-2016-00060 IN WHICH MY NAME AND THE SURGEON'S NAME ARE MISSING. AS OF TO DATE, NEITHER KLS MARTIN (AS PRODUCER, DISTRIBUTOR, AND SELLER OF THESE ORTHOGNATHIC IMPLANTS AND DEVICES), THE SURGEON, OR THE HOSPITAL TOOK ANY STEP FURTHER TO RESOLVE THE PROBLEM CREATED BY THEM TO ME. REF # 9610905-2016-00060.

    Description of Event or Problem · 1

    ON (B)(6) 2014, I HAD UPPER AND LOWER JAW SURGERY. MAXDRIVE SCREWS (KLS MARTIN LP) WERE USED TO FIXATE MAXILLA AND MAXDIBLE. A MAXDRIVE SCREW BROKE DURING THE MAXILLA FIXATION AND ENTERED IN MY LEFT SINUS CAVITY. SINCE THAT INCIDENT I REMAINED WITH THE BODY OF THE SCREW IN MY LEFT SINUS CAVITY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, I HAD UPPER AND LOWER JAW SURGERY. MAXDRIVE SCREWS (KLS MARTIN LP) WERE USED TO FIXATE MAXILLA AND MAXDIBLE. A MAXDRIVE SCREW BROKE DURING THE MAXILLA FIXATION AND ENTERED IN MY LEFT SINUS CAVITY. SINCE THAT INCIDENT I REMAINED WITH THE BODY OF THE SCREW IN MY LEFT SINUS CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755914 MAXDRIVE SCREW LOG213732 PLATE, FIXATION, BONE HRS KLS MARTIN LP

    Patients

    Seq Age Sex Outcome Treatment
    0 Other| R
    1 45 YR Other| O| R| R LEVOTHYROXINE| PAXIL| YASMINE