BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES

    MDR report key: 4798224 · Received May 27, 2015

    Report

    Report Number
    0001032347-2015-00231
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    April 23, 2015
    Report Date
    August 17, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK972322
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. FILE TWO OF TWO FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. FIELDS WERE UPDATED BASED ON THE DEVICE BEING RECEIVED FOR EVALUATION. SUPPLEMENTAL REPORT ONE OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2015-00230-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREWS WERE EVALUATED FOR THE COMPLAINT THAT THE SCREWS COULD NOT BE INSERTED INTO THE PATIENT¿S CRANIAL BONE. UPON EVALUATION THE COMPLAINT WAS CONFIRMED AS THE SCREW TIPS WERE BROKEN. THE SCREW DIMENSIONS WERE EVALUATED USING AN OVERLAY AND THE REMAINING THREADS WERE FOUND TO BE WITHIN TOLERANCE. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE MOST LIKELY UNDERLYING CAUSE OF THE DEFORMATION IS EXCESSIVE FORCE APPLIED DURING HANDLING OR INSERTION OF THE SCREW. SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2015-00230-2.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SCREWS COULD NOT BE INSERTED. THEY ARE UNABLE TO CONFIRM BUT STATE IT IS POSSIBLE A SMALL SLIVER OF THE SCREW MAY HAVE BEEN RETAINED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343582 LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES BONE SCREW JEY BIOMET MICROFIXATION N/A 696740

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability