BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP MIS

    MDR report key: 9786270 · Received March 4, 2020

    Report

    Report Number
    3009962553-2019-00004
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    April 23, 2019
    Report Date
    September 19, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    NKB
    UDI-DI
    03707780615032
    PMA / PMN Number
    K162367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED. 12/20/2019 - THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED.

    Description of Event or Problem · 0

    THE SET SCREW WOULD NOT START AND ENGAGE THE THREAD OF THE HEAD OF THE ERISMA-LP MIS POLYAXIAL SCREW. THERE WAS A DELAY OF 30 MINUTES ASSOCIATED WITH REMOVING THE SCREW AND REPLACING IT WITH AN ALTERNATIVE PEDICLE SCREW. HOWEVER, NO PATIENT HARM WAS REPORTED AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE SET SCREW WOULD NOT START AND ENGAGE THE THREAD OF THE HEAD OF THE ERISMA-LP MIS POLYAXIAL SCREW. THERE WAS A DELAY OF 30 MINUTES ASSOCIATED WITH REMOVING THE SCREW AND REPLACING IT WITH AN ALTERNATIVE PEDICLE SCREW. HOWEVER, NO PATIENT HARM WAS REPORTED AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253509 ERISMA-LP MIS 6.5MM X 40MM CANNULATED POLYAXIAL SCREW NKB CLARIANCE SAS 13016540 GA17C 03707780615032

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR