BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM ALLTHREAD PEEK W/2 .2 MA

    MDR report key: 3964437 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06520
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    February 25, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK080088
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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." THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06520 AND 06521).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF REPAIRMENT PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE SUTURES FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER ALLTHREAD PEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441118 5.5MM ALLTHREAD PEEK W/2 .2 MA SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A 160570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention