BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10517605 · Received September 10, 2020

    Report

    Report Number
    8030965-2020-06799
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    August 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE AND SCREW CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ITO H., ET AL (2019) CASE REPORT TREATMENT OF ATYPICAL FRACTURE OF THE ULNAR DIAPHYSIS BY OPEN REDUCTION AND INTERNAL FIXATION WITH TERIPARATIDE, CASE REPORTS IN ORTHOPEDICS ARTICLE ID 9103412, PAGES 1-5 (JAPAN). THIS STUDY PRESENTS A CASE REPORT OF FEMALE PATIENT TO DESCRIBE AN ATYPICAL FRACTURE OF THE ULNAR DIAPHYSIS. A CASE OF A (B)(6) YEAR OLD WOMAN PRESENTED AFTER FALLING FROM AN UPRIGHT POSITION ON HER LEFT HAND AND THEN EXPERIENCING DIFFICULTY ELEVATING HER LEFT ARM. SHE HAD A SIX-MONTH HISTORY OF MILD PAIN IN HER LEFT ELBOW AND A 10-YEAR HISTORY OF MEDICATION WITH BISPHOSPHONATE (ALENDRONATE), TO TREAT OSTEOPOROSIS. A LATERAL RADIOGRAPH OF THE LEFT FOREARM UPON PRESENTATION REVEALED A TRANSVERSE FRACTURE AT THE POSTEROLATERAL ASPECT OF THE PROXIMAL ULNA. COMPUTED TOMOGRAPHY OF THE LEFT ULNA SHOWED CORTICAL THICKENING, WITH TRANSVERSE FRACTURES AND SPIKE FORMATION ON THE VOLAR SIDE BIOCHEMICAL FINDINGS SHOWED NORMAL SERUM CALCIUM, PHOSPHATE, ALKALINE PHOSPHATASE, AND THYROID HORMONE VALUES. THE FRACTURE WAS DIAGNOSED AS ATYPICAL, AND BISPHOSPHONATE THERAPY WAS STOPPED. THE PATIENT UNDERWENT OPEN REDUCTION WITH INTERNAL FIXATION (ORIF) USING A 3.5MM LOCKING COMPRESSION PLATE (DEPUY SYNTHES, ZEIST, NETHERLANDS) FOR THE ULNAR FRACTURE. A TRANSVERSE FRACTURE WITH CORTICAL THICKENING WAS EVIDENT DURING THE PROCEDURE. PLAIN RADIOGRAPHY SHOWED NO SIGNS OF FRACTURE HEALING AT THREE MONTHS POSTOPERATIVELY, WHEN THE PATIENT COMPLAINED OF PAIN AT THE FRACTURE SITE. THE RESULTS OF A PHYSICAL EXAMINATION AND LABORATORY TESTS, INCLUDING WHITE BLOOD CELL COUNTS, C-REACTIVE PROTEIN, AND ERYTHROCYTE SEDIMENTATION RATE, WERE NORMAL, WHICH RULED OUT AN UNDERLYING INFECTION OF THE SURGICAL SITE. WE DIAGNOSED THE FRACTURE SITE AS NONUNION; THUS, WE PERFORMED THE REVISION SURGERY TO STABILIZE AND TO ACHIEVE A UNION OF THE FRACTURE SITE AT 4 MONTHS AFTER THE FIRST OPERATION USING A LOCKING PLATE INDICATED FOR OLECRANON FRACTURES (DEPUY SYNTHES, ZEIST, NETHERLANDS. IMMEDIATELY AFTER THIS PROCEDURE, LOW-INTENSITY PULSED ULTRASOUND (LIPUS) (SAFHS; TEIJIN PHARMA, TOKYO, JAPAN) WAS APPLIED ONCE A DAY FOR 20 MINUTES. HOWEVER, A CALLUS WAS NOT OBSERVED, AND BONY ABSORPTION WAS VISIBLE AT THE BONE GRAFT SITE AT TWO MONTHS AFTER THE REOPERATION. THEREFORE, THE PATIENT CONSENTED TO EMPIRICAL, OFF-LABEL THERAPY WITH TERIPARATIDE AT DOSES APPROVED TO TREAT OSTEOPOROSIS (20 ¿G/DAY). AFTER 19 MONTHS ON TERIPARATIDE, X-RAYS REVEALED BONE BRIDGES AND A DECREASED GAP BETWEEN THE FRAGMENTS. HEALING AFTER 30 MONTHS OF TREATMENT WITH LIPUS AND TERIPARATIDE WAS COMPLETE, AND THIS COINCIDED WITH THE DISAPPEARANCE OF PAIN AND A COMPLETE RANGE OF ELBOW AND WRIST JOINT MOTION. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5MM LOCKING COMPRESSION PLATE AND UNKNOWN SYNTHES LOCKING PLATE INDICATED FOR OLECRANON FRACTURES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978436 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention