BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT

    MDR report key: 6062066 · Received October 27, 2016

    Report

    Report Number
    0001032347-2016-00621
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. UNIQUE IDENTIFIER (UDI) # (B)(4). REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 0001032347-2016-00620.

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THAT THE ISSUE WAS CORRECTED AND THEN SHIPPED TO THE CUSTOMER; THEREFORE THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. THE PRODUCT IDENTITY COULD NOT BE CONFIRMED AND THE COMPLAINT COULD NOT BE VERIFIED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO PICTURES OF THE ISSUE WAS PROVIDED. A REVIEW OF THE TRANSACTION HISTORY SHOWS THAT THE IMPLANT WAS PROCESSED AND SHIPPED ON THE SAME DAY. THE DEVELOPMENT ENGINEERS DETERMINED THE MOST-LIKELY CAUSE OF THE COMPLAINT TO BE OPERATOR ERROR DURING THE PACKAGING PROCESS - THE PRODUCT WAS PLACED IN THE INCORRECT PACKAGE BY THE PACKAGING PERSONNEL. ACCORDING TO THE INVESTIGATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2016-00620-1.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO PATIENT MATCHED IMPLANTS WERE RECEIVED IN THE WRONG BOXES. THIS WAS IDENTIFIED IN THE WAREHOUSE PRIOR TO SHIPPING TO THE IMPLANTING FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711490 HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (PMI) KKY BIOMET MICROFIXATION N/A 708120

    Patients

    Seq Age Sex Outcome Treatment
    1