BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

    MDR report key: 4717842 · Received April 22, 2015

    Report

    Report Number
    0001032347-2015-00181
    Event Type
    Injury
    Date Received
    April 22, 2015
    Date of Event
    February 14, 2015
    Report Date
    March 24, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK110574
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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 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. FILE ONE OF FIVE FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS COMPLETED ON JULY 24, 2015. THE RETURNED SCREWS AND PLATES WERE EVALUATED FOR THE COMPLAINT THAT SCREW BACK OUT WAS FOUND DUE TO OOZING. UPON EVALUATION THE COMPLAINT WAS UNSUBSTANTIATED AS NO DEFECTIVE CONDITION WAS FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT ISSUE CANNOT BE DETERMINED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. PHOTOGRAPHIC IMAGES MADE DURING EVALUATION. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED - CAUSE OF EVENT UNKNOWN. SUPPLEMENTAL REPORT ONE OF FIVE FOR THE SAME EVENT, SEE ALSO 1032347-2015-00182-1, 1032347-2015-002183-1, 1032347-2015-00184-1, AND 1032347-2015-00185-1.

    Description of Event or Problem · 1

    ON JUNE 24, 2015 THE CUSTOMER REPORTED A CORRECTION TO THE ORIGINAL COMPLAINT REPORT "THE CUSTOMER REPORTED ONE SCREW LOOSENED DUE TO OOZING ON (B)(6) 2015. THERE WERE NO COMPLAINTS OF PAIN OR ABNORMITY FROM PATIENT. THE LOOSE SCREW WAS EXPLANTED USING LOCAL ANESTHESIA." THE CUSTOMER REPORTS THE STATEMENT THAT ONLY THE LOOSE SCREW WAS EXPLANTED USING LOCAL ANESTHESIA IS INCORRECT. IN ADDITION, WHEN ASKED WHY ALL THE IMPLANTS WERE EXPLANTED THE CUSTOMER RESPONDED "THE REASON OF WHY ALL IMPLANTS WERE REMOVED WAS SURGEON'S CONSIDERATION."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT HAD AN AORTIC VALVE REPLACEMENT PERFORMED AND THE STERNUM WAS CLOSED USING WIRE. THE DATE OF THIS PROCEDURE IS UNKNOWN AND NO BIOMET PRODUCTS WERE USED. ON (B)(6) 2015, THE WIRES WERE REMOVED DUE TO STERNAL DEHISCENCE AND STERNALOCK BLU IMPLANTS WERE IMPLANTED. THE CUSTOMER REPORTED ONE SCREW LOOSENED DUE TO OOZING ON (B)(6) 2015. THERE WERE NO COMPLAINTS OF PAIN OR ABNORMITY FROM PATIENT. THE LOOSE SCREW WAS EXPLANTED USING LOCAL ANESTHESIA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO EXPLANT ALL OF THE STERNALOCK BLU IMPLANTS DUE TO STERNAL DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268568 BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM BONE SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R