BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM-STERILE

    MDR report key: 9689980 · Received February 10, 2020

    Report

    Report Number
    8030965-2020-01019
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KWQ
    UDI-DI
    07611819957879
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRO-CODE: OVE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 04.617.814.02S, LOT: 9070839, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 04.AUGUST 2014, EXPIRY DATE: 01.JULY 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION THE SCREW BECAME CROSS THREADED AND WAS NECESSARY TO OPEN MORE STERILE SCREWS. THE ITEM WAS DISCARDED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148575 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM-STERILE APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ OBERDORF SYNTHES PRODUKTIONS GMBH 9070839 07611819957879

    Patients

    Seq Age Sex Outcome Treatment
    1