BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA ZS SPINAL FIXATION SYSTEM

    MDR report key: 2850798 · Received November 9, 2012

    Report

    Report Number
    9617297-2012-00001
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 29, 2012
    Manufacturer
    U&I CORPORATION
    Product Code
    MNI
    PMA / PMN Number
    K020279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO SAY THAT THIS EVENT OCCURRED BY PRODUCT'S DEFECT STILL NEEDS TO BE DETERMINED - MORE INFORMATION ON THE PATIENT, THE CONDITIONS OF THE IMPLANTATION AND THE OCCURRENCES LEADING TO THE EVENT ARE REQUIRED. INVESTIGATION FOR ADDITIONAL INFORMATION WAS INITIATED - DEVICES ARE REQUIRED TO BE SENT BACK TO U & I FOR ANALYSIS, THE DISTRIBUTOR IN THE FIELD WAS ASKED TO RETRIEVE THE INFORMATION ON THE PATIENT, THE CONDITIONS OF IMPLANTATION AND THE OCCURRENCES LEADING TO THE EVENT ALLOWING A FINAL REPORT TO BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT IS MALE, (B)(6). HE WAS TREATED WITH OPTIMA ON (B)(6) 2004. AFTER THAT, 3 OPTIMA SCREWS WERE BROKEN AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012. TWO BROKEN SCREWS (6.0 X 35 MM) IN S1 AND ONE BROKEN SCREW (5.0 X 50 MM) IN L5. BONE QUALITY WAS UNKNOWN AND EVENTS LEADING TO DISCOVERY OF BROKEN SCREWS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA ZS SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI U&I CORPORATION A03A013 (2EA), A02H0

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R