BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8557430 · Received April 26, 2019

    Report

    Report Number
    8030965-2019-63184
    Event Type
    Death
    Date Received
    April 26, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: BASTIAN, J AND HERTEL, R (2008), INITIAL POST-FRACTURE HUMERAL HEAD ISCHEMIA DOES NOT PREDICT THE DEVELOPMENT OF NECROSIS, JOURNAL OF SHOULDER AND ELBOW SURGERY, VOL. 17(1), PAGES 2-8 (SWITZERLAND). THE AIM OF THIS ARTICLE IS TO EVALUATE THE FUNCTIONAL OUTCOME AND THE OCCURRENCE OF AVASCULAR NECROSIS IN 51 CONSECUTIVE PATIENTS (26 FEMALE AND 25 MALE) WITH A MEAN AGE OF 44 YEARS (RANGE 21-60 YEARS) WITH INTRACAPSULAR FRACTURES OF THE PROXIMAL HUMERUS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION USING AN UNKNOWN SYNTHES 1/3 TUBULAR AO-PLATE BETWEEN FEBRUARY 1998 AND DECEMBER 2001. 7 PATIENTS WERE LOST TO FOLLOW-UP. 41 HEADS WERE INITIALLY PERFUSED (GROUP A) AND 10 WERE ISCHEMIC (GROUP B). THE MEAN FOLLOW-UP WAS 5 YEARS (RANGE 3.3 - 7.3 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 4 PATIENT DEATHS WERE REPORTED THESE PATIENTS WERE EXCLUDED FROM THE STUDY¿S LONG TERM EVALUATION. ASYMPTOMATIC FATIGUE FRACTURE OF THE PLATE OCCURRED IN 1 PATIENT, BUT NO REVISION WAS REQUIRED BECAUSE THE FRACTURE HAD CONSOLIDATED SOON AFTER PLATE FAILURE. REVISION SURGERY WAS REQUIRED FOR 17 COMPLICATIONS (STIFFNESS, ARTHROLYSIS, HEMATOMA, REFIXATION OF A DISPLACED GREATER TUBEROSITY). 14 PATIENTS HAD STRUCTURAL ALTERATIONS. 6 PATIENTS HAD COLLAPSED HEADS. (B)(6) YEAR-OLD WOMAN'S HUMERUS HEAD WAS PERFUSED, INTRAOPERATIVELY. 5 YEARS POSTSURGERY, RADIOLOGICAL ANALYSIS REVEALED STRUCTURAL ALTERATIONS IN THE HUMERAL HEAD. (B)(6) YEAR-OLD WOMAN'S HUMERUS HEAD WAS PERFUSED, INTRAOPERATIVELY. 7 YEARS POSTSURGERY, DESPITE INITIAL PERFUSION OF THE HEAD, ISCHEMIA OCCURRED, LEADING TO NECROSIS AND COLLAPSE OF THE SUBCHONDRAL PLATE. (B)(6) YEAR-OLD MAN HAD STRUCTURAL ALTERATIONS IN THE HUMERAL HEAD 4 YEARS POSTSURGERY. (B)(6) YEAR-OLD WOMAN HAD STRUCTURAL ALTERATIONS INT HE HUMERAL HEAD 6 YEARS POSTSURGERY. THE COMPLAINT INVOLVES 13 DEVICES. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 2 SEPARATE COMPLAINTS. THIS (B)(4) WILL INCLUDE 6 DEVICES AND (B)(4) WILL INCLUDE 7 DEVICES. THIS REPORT IS FOR UNKNOWN SCREWS. IT CAPTURES 4 DEATHS. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350171 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R