BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA ZS SPINAL FIXATION SYSTEM

    MDR report key: 2850797 · Received November 9, 2012

    Report

    Report Number
    9617297-2012-00002
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    April 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    PMA / PMN Number
    K020279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO SAY THAT THIS EVENT OCCURED 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 FOLLOW-UP REPORT TO BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT IS FEMALE AND SHE WAS TREATED WITH OPTIMA ON (B)(6) 2007. AFTER THAT, ONE OPTIMA SCREW WAS BROKEN AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012. SIZE OF BROKEN SCREW WAS 6.0X45MM. AGENT DIDN'T ATTEND SURGERY, THEREFORE ADDITIONAL INFORMATION (LEVEL OF VERTEBRA AND OTHER SPECIFIC INFORMATION FOR PATIENT) IS NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA ZS SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM KWQ U&I CORPORATION A06H053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R