BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 9973762 · Received April 17, 2020

    Report

    Report Number
    8030965-2020-02926
    Event Type
    Injury
    Date Received
    April 17, 2020
    Date of Event
    April 26, 2017
    Report Date
    March 25, 2020
    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 AN UNKNOWN CONSTRUCT PLATE-SCREW/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. (B)(4). 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: WAGNER F.C, ET AL. (2018), A NEW HOOK PLATE SYSTEM FOR OLECRANON FRACTURES AND OSTEOTOMIES, OBERE EXTREMITÄT, VOLUME 13, PAGE 38-44, (GERMANY). THE PURPOSE OF THIS STUDY WAS TO EVALUATE IF THE BIOMECHANICAL SUPERIORITY IS ALSO REFLECTED IN GOOD CLINICAL RESULTS AND LOW COMPLICATION RATE. FROM MAY 2009 AND DECEMBER 2013, 39 PATIENTS WITH OLECRANON FRACTURES WHO UNDERWENT TREATMENT WITH OLECRANON HOOK PLATE WERE INCLUDED IN THE STUDY. THERE WERE 24 WOMEN AND 15 MEN WITH A MEAN AGE OF 52.8 YEARS (RANGE 17-87 YEARS). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES 3.5 LOCKING COMPRESSION PLATE HOOK PLATE. FOLLOW-UP EXAMINATIONS INCLUDE POSTOPERATIVE RADIOGRAPHS AND CLINICAL FOLLOW-UPS WITH MAYO ELBOW PERFORMANCE SCORE (MEPS) AND LIVERPOOL ELBOW SCORE (LES). THE MEAN FOLLOW-UP WAS 55.7 (26-82) MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD FEMALE HAD A SECONDARY DISLOCATION OF THE OLECRANON OSTEOTOMY THAT OCCURRED 2 WEEKS AFTER THE TREATMENT OF A DISTAL HUMERUS FRACTURE. A REVISION WAS PERFORMED USING AN OLECRANON LCP AND RADIOLOGY SHOWED A COMPLETE CONSOLIDATION AFTER 14 WEEKS. AN (B)(6) YEAR-OLD FEMALE HAD A FALL 8 DAYS AFTER SURGERY WHICH LED TO A SECONDARY DISLOCATION OF THE FRACTURE INITIALLY TREATED WITH THE HOOK PLATE. THE PATIENT UNDERWENT REVISION WITH TENSION BELT OSTEOSYNTHESIS AND CONSOLIDATION WAS ACHIEVED AT 10 WEEKS POSTOPERATIVELY. A (B)(6) YEAR-OLD PATIENT HAD AN INFECTION WITH EVIDENCE OF (B)(6) AT 4 WEEKS POSTOPERATIVELY. INITIALLY, THE WOUND WAS DEBRIDED TWICE AND COLDEX INSERTS WERE APPLIED, FOLLOWED BY PREMATURE REMOVAL OF THE IMPLANT AT 6 WEEKS AFTER INITIAL OSTEOSYNTHESIS. THE INFECTION HEALED AFTERWARD AND FULL CONSOLIDATION WAS SHOWN AT 10 WEEKS POSTOPERATIVELY. AN (B)(6) YEAR-OLD PATIENT HAD A WOUND INFECTION WITH A STAPHYLOCOCCUS EPIDERMIDIS AT 9 DAYS POSTOPERATIVELY. INITIALLY, A ONE-TIME REVISION WITH IRRIGATION AND WOUND DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS THEN REVISED TO TENSION BELT OSTEOSYNTHESIS AT 5 WEEKS POSTOPERATIVELY. HEALING OCCURRED AND A CONSOLIDATION WAS VISUALIZED BY CONVENTIONAL RADIOLOGY AT 12 WEEKS POSTOPERATIVELY. A (B)(6) YEAR-OLD FEMALE PATIENT HAD WOUND DEHISCENCE WITHOUT GERM DETECTION THAT OCCURRED AT 3 WEEKS POSTOPERATIVELY. AFTER SURGICAL WOUND DRESSING, THE PATIENT WAS REVISED TO A TENSION BELT AND OSTEOSYNTHESIS HEALING OCCURRED. THE COURSE OF CONSOLIDATION WAS NOT CLOSELY MONITORED BY CONVENTIONAL RADIOLOGY BECAUSE THE PATIENT WAS PREGNANT. AT 10 MONTHS POSTOPERATIVELY, THE OSTEOTOMY WAS CONSOLIDATED IN ANATOMICAL POSITION AND THE WIRE CERCLAGE WAS REMOVED WHEN THERE WAS SOFT TISSUE IRRITATION. 11 PATIENTS HAD EARLY PLATE REMOVAL DUE TO IMPEDING MATERIAL (SOFT TISSUE IRRITATION). THIS WAS PERFORMED ON AVERAGE AFTER 10.5 MONTHS (RANGE, 5-18 MONTHS). THIS REPORT IS FOR THE UNKNOWN SYNTHES 3.5 LOCKING COMPRESSION PLATE HOOK PLATE THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436287 UNK - CONSTRUCTS: PLATE/SCREWS PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention