BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL HEAD - 24MM

    MDR report key: 7685142 · Received July 13, 2018

    Report

    Report Number
    1651501-2018-00048
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 10, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    K032806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS FOR LOT NUMBER 221675 WAS REVIEWED. A QUANTITY OF 2 DEVICES WERE INSPECTED ON 06/05/2015. NO ABNORMALITIES OR NONCONFORMANCES WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE IMPLANT WAS ASSESSED BY ENGINEERING AND NO OUT OF TOLERANCE CONDITIONS, DEFECTS, ABNORMALITIES OR DAMAGE COULD BE IDENTIFIED. THE MOST LIKELY FAILURE MODE HERE WAS LOOSENING, RATHER THAN IMPLANT BREAKAGE, SEEING AS THERE IS NO EVIDENCE OF BREAKAGE ON THE RETURNED PARTS. BASED ON THE ASSESSMENT PERFORMED ON THE RETURNED DEVICE , INTEGRA IS UNABLE TO CONFIRM THE REPORTED NON-CONFORMANCE OR DETERMINE ROOT CAUSE. BASE UPON THE ASSESSMENT OF THE RETURNED THE DEVICE, THE ROOT CAUSE WAS MOST LIKELY LOOSING OR DISSOCIATION POSSIBLY FROM SURGICAL TECHNIQUE, PATIENT AFTER CARE COMPLIANCE, OR PATIENT ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT IN THE AGE RANGE BETWEEN 25 TO 35 YEARS OLD WITH MENTAL DISORDER HAD A BROKEN IMPLANT AFTER A SUICIDE ATTEMPT. THE PATIENT ARRIVED TO THE HOSPITAL WITH SEVERAL FRACTURES, AND AFTER X-RAYS EXAMINATION, THE IMPLANT WAS FOUND TO BE BROKEN AND A SURGERY WAS PERFORMED TO EXPLANT THE UNIT. CHRONOLOGY: ON (B)(6) 2018 A RADIAL HEAD EXCHANGE SURGERY WAS PERFORMED WITH THE IMPLANT. ON (B)(6) 2018 DURING ROUTINE CHECK, THE IMPLANT HEAD WAS FOUND TO BE "DISCHARGED". ON (B)(6) 2018 ADDITIONAL SURGERY WAS PERFORMED IN ORDER TO REMOVE THE UNIT AND PLACE A NEW IMPLANT. NO INJURY TO PATIENT REPORTED AND HIS CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530032 RADIAL HEAD - 24MM KATALYST BIPOLAR RADIA HEAD SYSTEM KWI ASCENSION ORTHOPEDICS 22-1675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other