BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8584752 · Received May 6, 2019

    Report

    Report Number
    8030965-2019-63557
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    January 13, 2016
    Report Date
    April 8, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: YEO, I ET AL, HIGH UNION RATES OF LOCKING COMPRESSION PLATING WITH CORTICAL STRUT ALLOGRAFT FOR TYPE B1 PERIPROSTHETIC FEMORAL FRACTURES, INTERNATIONAL ORTHOPAEDICS (2016) VOLUME 40(11), PAGES 2365¿2371 (SOUTH KOREA) DOI 10.1007/S00264-015-3107-X. THIS RETROSPECTIVE STUDY AIMS TO REPORT CLINICAL AND RADIOLOGIC RESULTS OF PATIENTS WHO HAD A UNIFIED CLASSIFICATION (UCS) TYPE B1 PERIPROSTHETIC FEMORAL FRACTURE TREATED BY OPEN REDUCTION AND INTERNAL FIXATION USING A LOCKING COMPRESSION PLATE WITH AN ANTERIOR CORTICAL STRUT ALLOGRAFT. BETWEEN MARCH 2009 TO SEPTEMBER 2014, A TOTAL OF 17 PATIENTS (1 MALE AND 16 FEMALE) WITH AN AVERAGE AGE OF 74 YEARS (RANGE, 57-92 YEARS) WITH A UNIFIED CLASSIFICATION (UCS) TYPE B1 PERIPROSTHETIC FEMORAL FRACTURE THAT WERE TREATED BY OPEN REDUCTION AND INTERNAL FIXATION WITH A LATERAL LOCKING COMPRESSION PLATE SUPPLEMENTED WITH AN ANTERIOR CORTICAL STRUT ALLOGRAFT WERE INCLUDED IN THE STUDY. FIXATION WAS DONE USING A LATERAL LOCKING COMPRESSION PLATE (LCP, SYNTHES (B)(4), SOLOTHURN, SWITZERLAND) OR LOCKING COMPRESSION PLATE-DISTAL FEMUR (LCP-DF, SYNTHES (B)(4)) IN COMBINATION WITH CORTICAL STRUT ALLOGRAFT. THE MEAN DURATION OF FOLLOW-UP TIME WAS 28 MONTHS (RANGE, 12-74 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS HAD AN IRRITATION OF THE ILIOTIBIAL BAND, AND BOTH REQUIRED REMOVAL OF THE PLATE. THIS REPORT IS FOR AN UNKNOWN SYNTHES SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377949 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention