BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8329648 · Received February 11, 2019

    Report

    Report Number
    8030965-2019-60894
    Event Type
    Injury
    Date Received
    February 11, 2019
    Report Date
    January 23, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SYNTHES 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: COHEN, M ET AL (2009). OSTEOSYNTHESIS OF PROXIMAL HUMERAL END FRACTURES WITH FIXED-ANGLE PLATE AND LOCKING SCREWS: TECHNIQUE AND RESULTS. REVISTA BRASILIERA DE ORTOPEDIA. VOLUME 44. NUMBER 2. PAGE 106-111. (BRAZIL). THE OBJECTIVE OF THIS STUDY WAS TO DESCRIBE THE TECHNIQUE OF USING A FIXED-ANGLE PLATE WITH PHILOS LOCKING SCREWS AND EVALUATE THE RESULTS IN 26 PATIENTS WITH TRAUMATIC INJURIES OF THE PROXIMAL HUMERUS WHO UNDERWENT OSTEOSYNTHESIS USING THIS TYPE OF IMPLANT. BETWEEN MARCH 2003 AND OCTOBER 2004, 26 PATIENTS, 14 FEMALES AND 12 MALES, WERE TREATED SURGICALLY DUE TO FRACTURE OF THE PROXIMAL HUMERUS. THE AVERAGE AGE OF PATIENTS WAS 57 YEARS (24-85 YEARS). PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM PLATES AND SCREWS. PATIENTS WERE FOLLOWED ON AN OUTPATIENT BASIS WITH CLINICAL AND RADIOGRAPHIC EXAMINATION. ASSESSMENT INCLUDES THE RANGE OF MOTION OF THE SHOULDER, FRACTURE HEALING, PATIENT SATISFACTION, AND THE PRESENCE OF COMPLICATIONS RELATED TO THE SURGICAL TECHNIQUE OR IMPLANT. CLINICAL EVALUATION WAS PERFORMED USING THE SYSTEM OF POINTS DEFINED BY THE UNIVERSITY OF CALIFORNIA AT LOS ANGELES (UCLA). COMPLICATIONS WERE REPORTED AS FOLLOWS: AN (B)(6) YEAR-OLD FEMALE WITH NEER TYPE 2 FRACTURE (AO TYPE A3) HAD A POSTOPERATIVE CONSOLIDATION WITH VARUS ANGULATION. PATIENT HAD AN ANTERIOR FLEXION OF 90 DEGREES, EXTERNAL ROTATION OF 30 DEGREES AND INTERNAL ROTATION AT LEVEL T10. POSTOPERATIVE UCLA SCORE IS 26 POINTS. A (B)(6) YEAR-OLD MALE PATIENT WITH NEER TYPE 3 (AO TYPE B1) FRACTURE HAD A POSTOPERATIVE CONSOLIDATION WITH VARUS ANGULATION. PATIENT HAD AN ANTERIOR FLEXION OF 150 DEGREES, EXTERNAL ROTATION OF 30 DEGREES AND INTERNAL ROTATION AT LEVEL T10. POSTOPERATIVE UCLA SCORE IS 29 POINTS. AN (B)(6) YEAR-OLD FEMALE PATIENT WITH NEER TYPE 2 FRACTURE (AO TYPE A3) HAD A POSTOPERATIVE CONSOLIDATION WITH VARUS ANGULATION. PATIENT HAD AN ANTERIOR FLEXION OF 90 DEGREES, EXTERNAL ROTATION OF 25 DEGREES AND INTERNAL ROTATION AT LEVEL L1. POSTOPERATIVE UCLA SCORE IS 26 POINTS. A (B)(6) YEAR-OLD MALE PATIENT WITH NEER TYPE 2 FRACTURE (AO TYPE B3) HAD AN ANTERIOR FLEXION OF 60 DEGREES. POSTOPERATIVE UCLA SCORE IS 17 POINTS. THIS REPORT IS FOR A (B)(6) YEAR-OLD MALE WHO HAD POSTOPERATIVE CONSOLIDATION WITH VARUS ANGULATION. THIS REPORT IS FOR UNKNOWN SYNTHES SCREWS. THIS IS REPORT 4 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118923 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention