BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 MM SYSTEM 4-HOLE EXTRA LONG STRAIGHT PLATE

    MDR report key: 5790166 · Received July 13, 2016

    Report

    Report Number
    0001032347-2016-00343
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    July 21, 2016
    Report Date
    June 22, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WILL NOT BE RETURNED BY THE HOSPITAL FOR AN EVALUATION. IT IS REPORTED THAT THE REVISION TOOK PLACE BECAUSE OF THE PATIENT'S CONDITION. 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. THIS IS REPORT 5 OF 5 FOR THE SAME EVENT. REPORTS 1 THROUGH 4 ARE REPORTED ON MFR # 0001032347-2016-00339 THROUGH 0001032347-2016-00342.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PRODUCT WAS NOT RETURNED, A DEVICE EVALUATION WAS CONDUCTED. BASED ON THE EVALUATION, FIELDS WERE UPDATED. THE PRODUCT IDENTITY WAS CONFIRMED THROUGH THE PATIENT MATCHED IMPLANT DESIGN FORM. DUE TO A REVISION TAKING PLACE TO EXPLANT THE IMPLANTS, THE COMPLAINT IS CONSIDERED CONFIRMED. HOWEVER, THE DISTRIBUTOR STATES "IT IS NO COMPLAINT CASE." THE DISTRIBUTOR MAKES NO ALLEGATIONS THE IMPLANT IS NOT PERFORMING AS INTENDED AND SUGGESTS INSTEAD THAT IT IS DUE TO PATIENT CONDITION. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS PATIENT CONDITION. AS THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS DUE TO PATIENT CONDITION. THE DISTRIBUTION HISTORY OF THESE PRODUCTS WERE REVIEWED AND ATTACHED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT 5 OF 5 FOR THE SAME EVENT. REPORTS 1 THROUGH 4 ARE REPORTED ON MFR # 0001032347-2016-00339-1 THROUGH 0001032347-2016-00342-1.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN IMPLANT WAS EXPLANTED DUE TO A SKIN NECROSIS. IT IS REPORTED THAT THE REVISION TOOK PLACE BECAUSE OF THE PATIENT'S CONDITION. A NEW IMPLANT WILL BE INSTALLED TO ACCOMMODATE THE PATIENT'S SKIN CONDITION. DATE OF EVENT IS THE DATE THE REVISION IS SCHEDULED TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445151 1.5 MM SYSTEM 4-HOLE EXTRA LONG STRAIGHT PLATE BONE PLATE JEY BIOMET MICROFIXATION N/A 893950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R