BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE

    MDR report key: 8223702 · Received January 7, 2019

    Report

    Report Number
    8030965-2019-59528
    Event Type
    Injury
    Date Received
    January 7, 2019
    Report Date
    December 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819152342
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 412.213S, LOT: L790865. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: FEB 26, 2018, EXPIRY DATE: FEB 01, 2028. NON-STERILE PART 412.213, LOT: L723146. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: JAN 09, 2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS APPLIED TO SURGERY FOR FEMORAL NECK FRACTURES. ON AN UNKNOWN DATE A FEMORAL NECK SYSTEM (FNS) WAS OBSERVED TO BE UNABLE TO SUPPORT THE FRACTURE SITE. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED TO HOSPITAL FOR FOLLOW UP OBSERVATION. RE-OPERATION FOR IMPLANTING AN ARTIFICIAL FEMORAL HEAD WILL BE PERFORMED ON AN UNKNOWN DATE. PATIENT OUTCOME WAS REPORTED AS IN OBSERVATION. THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16490 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L790865 07611819152342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention