BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERISMA-LP

    MDR report key: 8149918 · Received December 11, 2018

    Report

    Report Number
    3009962553-2018-00002
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    July 30, 2018
    Report Date
    December 6, 2018
    Manufacturer
    CLARIANCE SAS
    Product Code
    NKB
    UDI-DI
    03700780618323
    PMA / PMN Number
    K153326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEDICLE SCREW INVOLVED IN THIS FIXATION FAILURE, AS WELL AS THE SET SCREW LOOSENED, HAVE BEEN EXAMINED TO CHECK IF THEY HAVE BEEN DEGRADED DURING THE CONSTRUCT TIGHTENING. THE DIMENSIONAL ANALYSIS CONDUCTED DEMONSTRATES THAT BOTH PEDICLE SCREW AND SET SCREW ARE IN CONFORMITY WITH THE SPECIFICATIONS OF THE TECHNICAL DRAWINGS. THE VISUAL EXAMINATION DOES NOT INDICATE ANY ABNORMAL SURFACE ISSUE OR MATERIAL ISSUE.

    Description of Event or Problem · 1

    TWO WEEKS POST-OP ON A T10-L3 FUSION CONSTRUCT FOR VERTEBRAL FRACTURE TREATMENT, THE PEDICLE SCREW ON CONTRA-LATERAL SIDE WAS PULLED OUT OF PEDICLE. AS A CONSEQUENCE, THE SET SCREW LOOSENED. THE PATIENT NEEDED A REVISION SURGERY TO RESECURE THE CONSTRUCT. THE CONSTRUCT WAS LENGTHENED TO L4 AND PEDICLE SCREWS WHICH PULLED OUT WERE REPLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991283 ERISMA-LP PEDICLE SCREW NKB CLARIANCE SAS 18176550 I265X 03700780618323

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention