BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 3963501 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06501
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    November 3, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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. DATE IMPLANTED - (B)(6) 2014. DATE EXPLANTED - (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT THE INITIAL NOTIFICATION DATE TO JULY 3, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVERSE SHOULDER PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE BASEPLATE SCREWS FRACTURED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER PROCEDURE IN (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED IN (B)(6) 2014 DUE TO THE BASEPLATE PULLING AWAY FROM THE GLENOID AND FRACTURE OF CENTRAL SCREW CAUSING BONE LOSS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE IS PLANNED DUE TO THE BASEPLATE PULLING AWAY FROM THE GLENOID AND FRACTURE OF CENTRAL SCREW CAUSING BONE LOSS; HOWEVER, A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441588 UNKNOWN SCREW PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R