BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-DBLE LEAD CORT 5.0X65MM SCR

    MDR report key: 3050339 · Received April 10, 2013

    Report

    Report Number
    0001825034-2013-00907
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK063570
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE PLANNED REVISION WAS CANCELED, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. A REVISION PROCEDURE IS SCHEDULED FOR (B)(6) 2013. A FOLLOW UP REPORT TO PROVIDE DETAILS OF THE REVISION PROCEDURE WILL BE SENT TO THE FDA ONCE THE REVISION PROCEDURE HAS TAKEN PLACE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "BENDING OR FRACTURE OF THE IMPLANT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANKLE FUSION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THAT A SCREW IS FRACTURED. A REVISION PROCEDURE TO REMOVE AND REPLACE THE SCREW IS PLANNED FOR (B)(6) 2013. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANKLE FUSION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THAT A SCREW IS FRACTURED. A REVISION PROCEDURE TO REMOVE AND REPLACE THE SCREW HAD BEEN PLANNED BUT WAS CANCELLED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANKLE FUSION PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A SCREW FRACTURE. THE NAIL AND DISTAL SCREW WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154100 TI-DBLE LEAD CORT 5.0X65MM SCR ROD, FIXATION HSB BIOMET TRAUMA N/A 181210

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R