BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8219263 · Received January 4, 2019

    Report

    Report Number
    8030965-2019-59458
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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: KUMAR GNK. ET AL (2014), SURGICAL TREATMENT OF PROXIMAL HUMERUS FRACTURES USING PHILOS PLATE, CHINESE JOURNAL OF TRAUMATOLOGY, PAGES 279-284 ((B)(6)). THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE FUNCTIONAL OUTCOME AND COMPLICATIONS OF OPEN REDUCTION AND INTERNAL FIXATION WITH PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE FOR PROXIMAL HUMERUS FRACTURES. BETWEEN THE YEARS 2007 TO 2012, A TOTAL OF 51 (35 MALE, 16 FEMALE) PATIENTS WITH A MEAN AGE OF 38 YEARS (RANGE 24-68) WHO HAD PROXIMAL HUMERUS FRACTURES WERE INCLUDED IN THIS STUDY. THE PATIENTS UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE. THERE WERE 41 PATIENTS IN THE AGE GROUP OF <60 YEARS AND 10 PATIENTS IN THE AGE GROUP OF >60 YEARS. ACCORDING TO NEER CLASSIFICATION SYSTEM 8 PATIENTS HAD 2-PART FRACTURES,15 PATIENTS HAD 3-PART FRACTURES, 23 PATIENTS HAD 4-PART FRACTURES, AND 5 PATIENTS HAD 4-PART FRACTURE DISLOCATION. HEAD SPLITTING AND IMPACTION WERE NOTED IN 3 AND 2 PATIENTS RESPECTIVELY. FUNCTIONAL EVALUATION OF THE SHOULDER AT FINAL FOLLOW-UP WAS DONE USING CONSTANT-MURLEY SCORE. TWO PATIENTS WERE LOST TO FOLLOW-UP. OF THE REMAINING 49 PATIENTS, ALL FRACTURES WERE UNITED CLINICALLY AND RADIOLOGICALLY, HOWEVER, COMPLICATIONS WERE NOTED DURING FOLLOW-UP. CT SCANS WERE OBTAINED FROM 30 PATIENTS. THE MEAN TIME FOR RADIOLOGICAL UNION WAS 12 WEEKS (RANGE 8-20). THE MEAN FOLLOW-UP PERIOD WAS 30 MONTHS (RANGE 12-44 MONTHS). THE FOLLOWING REPORTED COMPLICATIONS IS FOR THE PATIENTS IMPLANTED WITH PHILOS PLATE: 4 CASES OF VARUS MALUNION. 1 PATIENT HAD INTRAOPERATIVE FRACTURE AT THE APEX OF THE PHILOS PLATE. 1 PATIENT EXPERIENCED SUBACROMIAL IMPINGEMENT. 1 PATIENT HAD DEEP INFECTION WHICH REQUIRED REOPERATION. 1 CASE OF INTRA-ARTICULAR SCREW PENETRATION. 1 PATIENT HAD FAILURE OF FIXATION DUE TO ARTICULAR COLLAPSE AND UNDERWENT RE-FIXATION WITH BONE GRAFTING. 5 PATIENTS HAD POOR CONSTANT-MURLEY SCORE FOR THE FUNCTIONAL EVALUATION OF THE SHOULDER. THE FOLLOWING CAPTURES THE PATIENT WITH DCP: UNKNOWN PATIENT HAD INTRAOPERATIVE FRACTURE AT THE APEX OF THE PHILOS PLATE FIXED WITH DCP. IT WAS NOT SPECIFIED IN THE ARTICLE WHICH COMPLICATION THE PATIENT EXPERIENCED. THUS, THE FOLLOWING COMPLICATIONS ARE ASSOCIATED WITH THIS PATIENT: VARUS MALUNION; SUBACROMIAL IMPINGEMENT; DEEP INFECTION WHICH REQUIRED REOPERATION; INTRA-ARTICULAR SCREW PENETRATION; FAILURE OF FIXATION DUE TO ARTICULAR COLLAPSE AND UNDERWENT RE-FIXATION WITH BONE GRAFTING; POOR CONSTANT-MURLEY SCORE FOR THE FUNCTIONAL EVALUATION OF THE SHOULDER. THIS REPORT IS FOR AN UNKNOWN SYNTHES PHILOS PLATE. THIS IS REPORT 1 OF 3 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
    9087 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention