BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE

    MDR report key: 9235740 · Received October 24, 2019

    Report

    Report Number
    8030965-2019-69675
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089953
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.168.485S. LOT: L961533. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 04 JULY 2018. EXPIRY DATE: 01 JUNE 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR LEFT FEMORAL NECK FRACTURE WITH THE FEMORAL NAIL SYSTEM (FNS). THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO SURGICAL DELAY. THE FRACTURE TYPE WAS AO31B1.2 (AO CLASSIFICATION). ON (B)(6) 2019, THE PATIENT FELL DOWN. ON (B)(6) 2019, THE PATIENT VISITED THE HOSPITAL, AND THE HOSPITAL CONFIRMED THAT THE INSUFFICIENCY FRACTURE OCCURRED AT AROUND THE LOCKING SCREW HOLE. THE PATIENT UNDERWENT THE REMOVAL SURGERY OF THE FNS AND THE IMPLANT SURGERY OF THE TFNA LONG ON (B)(6) 2019. THE ORIGINAL FEMORAL NECK FRACTURE WAS UNITED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THERE WAS NO PRODUCT DEFECT. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYSTEM 85MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029560 ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L961533 07612334089953

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention