BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8620081 · Received May 17, 2019

    Report

    Report Number
    8030965-2019-64083
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    April 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 148 PATIENTS (48 MALE AND 100 FEMALE) WITH A MEAN AGE OF 80.0 YEARS (RANGE, 22-96 YEARS). THIS REPORT IS FOR AN UNKNOWN SYNTHES DYNAMIC HIP SYSTEM (DHS) LAG SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VERHOFSTAD , M. ET AL (2004), DHS OSTEOSYNTHESIS FOR STABLE PERTROCHANTERIC FEMUR FRACTURES WITH A TWO-HOLE SIDE PLATE , INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED (2004) VOLUME 35(10) PAGES 999-1002 (NETHERLANDS). THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE RESULTS OF TREATMENT OS A STABLE PERTROCHANTERIC FEMUR FRACTURE WITH A TWO-HOLE PLATE DYNAMIC HIP SCREW(DHS).BETWEEN 1995 AND 2001 , A TOTAL OF 148 PATIENTS (48 MALE AND 100 FEMALE) WITH A MEAN AGE OF 80.0 YEARS (RANGE, 22-96 YEARS) WITH A STABLE PERTROCHANTERIC FEMUR FRACTURE WHO WERE TREATED WITH A DYNAMIC HIP SCREW (DHS) AND A SHORT (TWO-HOLE) SIDE PLATE AND IMMEDIATE FULL WEIGHT BEARING MOBILISATION WERE INCLUDED IN THE STUDY. TREATMENT WAS DONE WITH A DYNAMIC HIP SCREW (DHS; MATHYS MEDICAL, BETTLACH, SWITZERLAND) WITH A TWO-HOLE SIDE PLATE WITH TWO 4.5 MM BICORTICAL SCREWS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO CASES OF CUT OUT OF THE SLIDING SCREW DUE TO POOR PLACEMENT WAS SEEN. THIS REPORT IS FOR AN UNKNOWN SYNTHES DYNAMIC HIP SYSTEM (DHS) LAG SCREW. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412991 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention