BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8362024 · Received February 22, 2019

    Report

    Report Number
    8030965-2019-61296
    Event Type
    Injury
    Date Received
    February 22, 2019
    Report Date
    January 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    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: KLITSCHER, D ET AL (2008). OSTEOSYNTHESIS OF PROXIMAL HUMERAL FRACTURES WITH THE FIXED ANGLE PHILOS-PLATE. EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY. VOLUME 34. PAGE 29-36. (GERMANY). THIS RETROSPECTIVE STUDY ANALYZED THE FUNCTIONAL AND RADIOLOGICAL OUTCOME OF 30 PROXIMAL HUMERAL FRACTURES, TREATED BY PHILOS-PLATE, A FIXED-ANGLE DEVICE. FROM APRIL 2002 TO AUGUST 2004, 46 PATIENTS WITH A PROXIMAL HUMERAL FRACTURE WERE TREATED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE FIXATION. HOWEVER, 16 PATIENTS WERE LOST TO FOLLOW-UP, 4 LIVE MORE THAN 200 KM AWAY AND 3 CHANGED ADDRESS. THEREFORE, ONLY A TOTAL OF 30 PATIENTS WERE INCLUDED IN THE STUDY. 11 PATIENTS WERE MALE AND 19 WERE FEMALE WITH A MEAN AGE OF 59 YEARS (RANGE: 22¿84 YEARS). PATIENTS WERE FOLLOWED UP BY CLINICAL AND RADIOGRAPHIC ASSESSMENT. AN EVALUATION OF CLINICAL RESULTS WAS PERFORMED USING THE CONSTANT-SCORE, THE NORMALIZED CONSTANT-SCORE DESCRIBED BY KATOLIK ET AL., AND THE UCLA-RATING SYSTEM. THE AVERAGE PERIOD OF FOLLOW-UP WAS 16.4 MONTHS (RANGE: 12¿36 MONTHS). COMPLICATIONS WERE REPORTED AS FOLLOWS: 4 PATIENTS HAD MODERATE PAIN. 4 PATIENTS HAD PARTIAL NECROSIS OF THE HUMERAL HEAD. 1 PATIENT HAD DELAYED UNION. 1 PATIENT HAD MALUNION WITH RETROVERSION AND VARUS DISPLACEMENT OF THE HUMERAL HEAD. 19 PATIENTS HAD SECONDARY VARUS DISPLACEMENT OF 5 TO 35 DEGREES WITH A MEAN OF 7 DEGREES. 4 PATIENTS HAD POOR RESULTS IN CONSTANT-SCORE. 5 PATIENTS HAD POOR RESULTS IN CONSTANT-SCORE NORMALIZE FOR AGE AND GENDER. 3 PATIENTS HAD POOR RESULTS IN UCLS-SCORE. 1 PATIENT HAD LOOSENING OF PLATE AND SCREW. REFIXATION WITH A PHILOS-PLATE WAS PERFORMED. 3 PATIENTS HAD SCREW PERFORATION. THIS REPORT IS FOR UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM PLATES. IT CAPTURES LOOSENING, REVISED. THIS IS REPORT 3 OF 4 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154731 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention