BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM

    MDR report key: 5679958 · Received May 25, 2016

    Report

    Report Number
    2520274-2016-12871
    Event Type
    Injury
    Date Received
    May 25, 2016
    Report Date
    May 10, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT HEIGHT IS 5 FEET 7 INCHES. (B)(6). ADDITIONAL DEVICE PRODUCT CODE IS JDO. (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    CONCOMITANT MEDICAL DEVICE 214.838, 4.5MM CORTEX SCREW SELF-TAPPING; WAS REPORTED AS (2), SHOULD ONLY BE: ONE (1). (B)(6). 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 A LAG SCREW CUT OUT. A PATIENT WITH POOR BONE QUALITY WAS IMPLANTED WITH A DYNAMIC HIP SCREW SYSTEM ON (B)(6) 2016 FOR TREATMENT OF A RIGHT SIDED INTERTROCHANTERIC FRACTURE. SUBSEQUENT X-RAY (DATE UNKNOWN) SHOWED CUT OUT OF THE LAG SCREW PROXIMALLY. ON (B)(6) 2016, THE LAG SCREW, PLATE, COMPRESSION SCREW AND FOUR CORTEX SELF-TAPPING SCREWS WERE EXPLANTED INTACT WITH NO SURGICAL DELAY. THE PATIENT WAS REVISED TO A SYNTHES 125 DEGREE TROCHANTERIC FIXATION NAIL. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME WAS STABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334910 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM APPLIANCE, FIXATION, NAIL KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention