BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PEKK BAILEY RT FT SP PAR T

    MDR report key: 3170168 · Received June 14, 2013

    Report

    Report Number
    0001032347-2013-00199
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    PK121818
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE "THE HTR-PEKK DEVICE IS CONSTRUCTED WITH THE USE OF THE PATIENT¿S CT IMAGING DATA AND COMPUTER AIDED DESIGN TO DETERMINE THE DIMENSIONS OF EACH IMPLANT. IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE HTR-PEKK DEVICE MAY CAUSE AN UNDESIRABLE RESULT. THE SURGEON IS TO BE FAMILIAR WITH THE IMPLANT AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY." WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE, THERE WAS NO SIGNIFICANT SURGICAL DELAY RELATED TO THE IMPLANT. WITH RECEIPT OF THIS INFORMATION, THE EVENT IS NO LONGER REPORTABLE AND THE COMPLAINT FILE WILL BE CLOSED ACCORDINGLY. FOLLOW UP WITH THIS SALES REPRESENTATIVE CLARIFIED THAT THE DELAY IN THE CASE WAS QUOTED AT ¿15 MINUTES¿ WHICH IS NOT CONSIDERED SIGNIFICANT SURGICAL DELAY. THE ORIGINAL INFORMATION HAD INDICATED A TWO HOUR DELAY HOWEVER THIS WAS CLARIFIED TO BE THE LENGTH OF THE CASE AND NOT THE LENGTH OF DELAY.

    Description of Event or Problem · 1

    CORRECTED LOT AND MANUFACTURER INFORMATION.

    Description of Event or Problem · 1

    DISTRIBUTOR (B)(4) REPORTS HTR PEKK IMPLANT SIZE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271324 HTR-PEKK BAILEY RT FT SP PAR T HARD TISSUE REPLACEMENT GXN BIOMET MICROFIXATION N/A IG3015M-07F001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization