BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5864629 · Received August 10, 2016

    Report

    Report Number
    2520274-2016-13960
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 8, 2009
    Report Date
    July 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN ASIF CANCELLOUS BONE SCREW, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: MADSEN, F.ET ALL (2009). FIXATION OF DISPLACED FEMORAL NECK FRACTURES: A COMPARISON BETWEEN SLIDING SCREW PLATE (SSP) AND FOUR CANCELLOUS BONE SCREWS (ASIF). ACTA ORTHOPAEDICA SCANDINAVICA, 58, 212-216. DENMARK. IN A PROSPECTIVE, RANDOMIZED TRIAL, 104 CONSECUTIVE PATIENTS WITH DISPLACED FEMORAL NECK FRACTURES WERE ALLOCATED EITHER TO FIXATION WITH A SLIDING SCREW PLATE OR 4 ASIF CANCELLOUS BONE SCREWS. THE PATIENTS WERE REEXAMINED AT FIXED INTERVALS TO DETERMINE THE TIME OF UNION. THE AUTHORS COMPARED THE RATE OF UNION AFTER FIXATION WITH EITHER 4 ASIF CANCELLOUS BONE SCREWS OR A SLIDING SCREW PLATE. FIFTY ONE PATIENTS (FEMALE/MALE RATION 3.7, MEAN AGE 74, AGE RANGE 34-92 YEARS) WERE TREATED WITH A SSP AND 52 PATIENTS WITH ASIF SCREWS. OF THE 52 PATIENTS IN THE ASIF GROUP 8 EXPERIENCED COMPLICATIONS: (RM, SI) EIGHT PATIENTS AFTER UNION OF THE FRACTURE, EXPERIENCED A REMOVAL OF THE DEVICE BECAUSE OF LOCAL DISCOMFORT AND PENETRATION OF A SCREW. THIS REPORT IS FOR 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ASIF CANCELLOUS BONE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517463 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention