BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SESAMOID PLASTY SINGLE STAND - P7

    MDR report key: 7955690 · Received October 11, 2018

    Report

    Report Number
    0009617840-2018-00011
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    August 30, 2018
    Report Date
    January 9, 2019
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK110054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE DID NOT CAUSE A SERIOUS INJURY AND THE EVENT IS BEING REASSESSED AS NOT REPORTABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER SUSTAINED AN INJURY UPON LIFTING THE STAND OUT OF ITS CASE DURING A SALES DEMONSTRATION. THE ISSUE IS BEING HANDLED THROUGH AN EMPLOYEE INJURY PROGRAM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795772 SESAMOID PLASTY SINGLE STAND - P7 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other