BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZED POSITIONING SYSTEM

    MDR report key: 11600556 · Received March 31, 2021

    Report

    Report Number
    3012916784-2021-00084
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 18, 2021
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K171847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS PLAN AND DHA. NO OPTIMIZED ORTHO DEVICES WERE INTERFACING WITH THE PATIENT DURING THE SURGERY. THIS FAILURE MODE IS NOT ASSOCIATED WITH THE USE OF OPS PLAN AND DHA IN THE PRIMARY SURGERY. THERE IS NO EVIDENCE TO SUGGEST THAT THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY CONTRIBUTED TO THIS REVISION EVENT. THEREFORE THE CASE IS NOW CONSIDERED CLOSED. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PATIENT WAS REVISED DUE TO INFECTION. OPS PLAN WITH DHA WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PATIENT WAS REVISED DUE TO INFECTION. OPS PLAN WITH DHA WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495195 OPTIMIZED POSITIONING SYSTEM OPTIMIZED POSITIONING SYSTEM LZO OPTIMIZED ORTHO PTY LTD OPS PLAN WITH DHA MAR_MS_22015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention