BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON-TYPE HOOK 71/2 90D SSHP

    MDR report key: 4938378 · Received July 22, 2015

    Report

    Report Number
    2523190-2015-00043
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    February 27, 2015
    Report Date
    August 11, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 INTEGRA COMPLETED INVESTIGATION. THIS HOOK WAS MANUFACTURED AT LEAST 15 YEARS AGO. THE EXACT MANUFACTURING DATE IS UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE RETURNED HOOK SHOWING WEAR. UPON VISUALLY INSPECTING IT IS CONFIRMED THAT THE TIP IS BROKEN. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT IS CONFIRMED: ROOT CAUSE UNDETERMINED. NO MANUFACTURING DEFICIENCY HAS BEEN FOUND.

    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.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH #5041705 REPORTS SURGEON WAS PERFORMING AN ANTERIOR CERVICAL FUSION, HE NOTICED THAT THE INSTRUMENT (A RHOTON DISSECTOR) WAS MISSING A PART OF IT'S TIP. X-RAY WAS TAKEN AT THE END OF PROCEDURE AND WAS NEGATIVE FOR PRESENCE OF FOREIGN BODY IN THE INCISION SITE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477274 RHOTON-TYPE HOOK 71/2 90D SSHP NA GZX INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR