BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE

    MDR report key: 9135294 · Received September 30, 2019

    Report

    Report Number
    2939274-2019-61045
    Event Type
    Injury
    Date Received
    September 30, 2019
    Report Date
    September 4, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982274731
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 ON (B)(6) 2019, THE PATIENT PRESENTED IN THE CLINIC DUE TO POST-OPERATIVE PAIN ON THE HIP. AN X-RAY SHOWED NON-UNION WITH BROKEN ANTI-ROTATION SCREW AND POTENTIALLY THE BOLT IS BROKEN. THE DISTAL LOCKING SCREWS AND PLATE APPEAR TO BE INTACT. INITIALLY, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON AN UNKNOWN DATE. AT THIS POINT, NO REVISION SURGERY HAS BEEN SCHEDULED. CONCOMITANT MEDICAL PRODUCTS: TITANIUM LOCKING COMPRESSION PLATE (LCP) PROXIMAL LATERAL TIBIA (PART # 422.226, LOT # 2192572, QUANTITY 1). FEMORAL NECK SYSTEM PLATE (PART # 04.168.000S, LOT # UNKNOWN, QUANTITY 1). TITANIUM LOCKING SCREW (PART # 412.213S, LOT # UNKNOWN, QUANTITY 1) AND UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927258 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE APPLIANCE, FIXATION, NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.168.285S 10886982274731

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention