BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM

    MDR report key: 8095137 · Received November 21, 2018

    Report

    Report Number
    8030965-2018-58426
    Event Type
    Injury
    Date Received
    November 21, 2018
    Report Date
    November 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819268951
    PMA / PMN Number
    K023941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE DEVICE HISTORY LOT: PART: 413.375S, LOT: L150623, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 11.OCT.2016, EXPIRY DATE: 01.OCT.2026. 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 RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: 3 OF THE SCREWS WERE CUT DURING REMOVAL PROCEDURE. ALSO, THE 5 BLOCKED SCREWS WHICH ARE JAMMED IN THE PLATE DO NOT HAVE INFLUENCE ON THE REPORTED PROBLEM AS THEY COMPLETELY FULFILLED THEIR INTENDED FUNCTION. THERE IS NO ALLEGATION AGAINST THE IMPLANTS IN QUESTION. AS WE HAVE NOT RECEIVED ANY X-RAY PICTURES WE ARE NOT ABLE TO CONFIRM THE REPORTED BREAKAGE OF THE BONE. THEREFORE THIS COMPLAINT IS NOT CONFIRMED. AS ALL RECEIVED IMPLANTS ARE IN GOOD CONDITION, WE ARE NOT ABLE TO IDENTIFY ANY ROOT CAUSE FOR THE REPORTED PROBLEM AND NO FURTHER INVESTIGATION WILL BE PERFORMED. THIS DEVICE LEFT OUR DISTRIBUTION CHAIN IN FAULTLESS CONDITION AND DID NOT CAUSE THE REPORTED PROBLEM. NO PRODUCT FAILURE COULD BE IDENTIFIED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 THE HOSPITAL FOUND OUT THAT THERE WAS A BONE FRACTURE NEAR THE PROXIMAL SCREW, ON (B)(6) 2018, DUE TO AN UNKNOWN REASON. THE PATIENT UNDERWENT A CONSERVATIVE THERAPY SINCE THAT TIME. INTERNAL FIXATION SURGERY WAS PERFORMED WITH ONE (1) LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE AND ELEVEN (11) LOCKING SCREWS. PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2018. ALL PIECES WERE RETRIEVED, AND NO PIECES WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED BY SIXTY (60) MINUTES. NO ADVERSE EVENTS WERE CAUSED BY THE EXTENSION OF SURGERY TIME. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM. THIS IS REPORT 2 OF 2 FOR (B)(4). PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL TEN (10) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936854 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L150623 07611819268951

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention