BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8357634 · Received February 21, 2019

    Report

    Report Number
    8030965-2019-61212
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    January 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN PLATES. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN PLATES. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). 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: KUHLMANN T ET AL (2012). COMPARISON PHILOS VS. KÖNIGSEE PLATE OSTEOSYNTHESIS IN THE OPERATIVE TREATMENT OF 4- FRAGMENT FRACTURES OF THE PROXIMAL HUMERUS IN OVER 65-YEAR-OLD PATIENTS. ZEITSCHRIFT FUR ORTHOPADIE UND UNFALLCHIRURGIE. VOLUME 150. PAGES 149-155. (GERMANY). THE AIM OF THE PRESENT STUDY WAS A CLINICAL AND RADIOLOGICAL COMPARISON BETWEEN PHILOS (PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM, SYNTHES GMBH, UMKIRCH) AND KÖNIGSEE PLATES (KÖNIGSEE IMPLANTATE GMBH, ALLENDORF) IN THE TREATMENT OF NEER'S 4-FRAGMENT FRACTURES IN PATIENTS OVER 65 YEARS OF AGE , WHETHER DIFFERENT HUMERAL HEAD ANCHORING PHILOSOPHIES OF THE TWO OSTEOSYNTHESIS OPTIONS LEAD TO DIFFERENT RESULTS SHOULD BE CLARIFIED IN A RETROSPECTIVE FOLLOW-UP EXAMINATION. FROM JULY 2005 TO DECEMBER 2007, 60 PATIENTS WITH 60 4-PART FRACTURES OF THE PROXIMAL HUMERUS WHO WERE TREATED WITH 1 OF THE 2 IMPLANT SYSTEMS AND FOLLOWED UP AFTER A MEDIAN OF 17 MONTHS (12-24) WERE INCLUDED IN THE STUDY. THERE WERE 39 FEMALES AND 21 MALES WITH A MINIMUM AGE OF 65 YEARS OLD. 30 PATIENTS (10 MALES AND 20 FEMALES, MEAN AGE OF 69 YEARS (RANGE, 65-92 YEARS) WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM PLATES WHILE THE OTHER 30 PATIENTS WERE IMPLANTED WITH A COMPETITOR¿S DEVICE. ALL PATIENTS WERE FOLLOWED UP FOR AT LEAST 12 MONTHS AFTER SURGERY AND SHOULDER FUNCTION WAS MEASURED WITH THE CONSTANT SCORE. CONSTANT AND MURLEY, SUBJECTIVE AND OBJECTIVE PARAMETERS ARE COMBINED TO A MAXIMUM OF 100 POINTS. THE SCORE "VERY GOOD" IS REACHED FROM 86 POINTS. POINTS 71-85 ARE RATED "GOOD", POINTS 56-70 "SATISFACTORY". A SCORE OF LESSER THAN 56 POINTS IS CONSIDERED "BAD". IN ADDITION, THE AMERICAN SHOULDER AND ELBOW SURGEONS SCORE (ASES) SCORE OF 100 POINTS AND THE DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND SCORE) SCORE WERE USED TO ASSESS UPPER LIMB MUSCULOSKELETAL FUNCTION. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A POSTOPERATIVE EARLY INFECTION. THIS RESULTED IN PREMATURE METAL REMOVAL AFTER 10 DAYS. 3 PATIENTS HAD PARTIAL HUMERAL HEAD NECROSIS THAT WAS DETECTED IN AN X-RAY DIAGNOSTIC. 2 PATIENTS ACHIEVED BAD RESULTS IN CONSTANT SCORES. THIS REPORT IS FOR UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151277 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention