BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8620441 · Received May 17, 2019

    Report

    Report Number
    8030965-2019-64090
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    April 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. 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: JIME´NEZ-DI´AZ, V. ET AL (2016), ANALYSIS OF COMPLICATIONS AFTER A FLOATING ELBOW INJURY, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY JULY 2017, VOLUME 27(5) PAGES 607-615 (FRANCE) DOI:10.1007/S00590-016-1866-8. THIS RETROSPECTIVE STUDY AIMS TO ANALYSE COMPLICATIONS AFTER A FLOATING ELBOW INJURY, ATTEMPTING TO ESTABLISH WHICH OF THEM ACT AS A POOR PROGNOSIS FACTOR REGARDING CLINICAL AND FUNCTIONAL RESULTS. FROM 2004 TO 2013, A TOTAL OF 23 PATIENTS (19 MALE AND 4 FEMALE) WITH AN AVERAGE AGE OF 35.86 YEARS (RANGE, 10.8-24.3 YEARS) WHO SUFFERED A FLOATING ELBOW INJURY WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO FOUR (4) GROUPS DEPENDING ON THE TYPE OF INJURY. FIFTEEN CASES IN DIAPHYSEAL FRACTURE; IN THE CASE OF DISTAL THIRD INTRA-ARTICULAR FRACTURES MOST FREQUENTLY TECHNIQUE USED WAS OSTEOSYNTHESIS WITH PRECONTOURED PLATES (LCP, SYNTHES, SWITZERLAND). FOR FOREARM FRACTURES, THE MOST FREQUENT TECHNIQUE USED FOR OSTEOSYNTHESIS WAS COMPRESSION PLATING WITH LOW-CONTACT DYNAMIC COMPRESSION PLATES (LC-DCP) OR LOCKING COMPRESSION PLATES (LCP). THE AVERAGE FOLLOW-UP WAS 14.45 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF A (B)(6) YEAR OLD HAD RADIAL NERVE INJURY. A CASE OF A (B)(6) YEAR OLD HAD INFECTION AND RADIAL NERVE INJURY. A CASE OF A (B)(6) YEAR OLD WITH SCAPULAR FRACTURE DISTAL RADIUS FRACTURE HAD INFECTION ,ULNAR NERVE INJURY, AND RADIOULNAR SYNOSTOSIS. HAD 65 SCORE IN MEPS , 90 DEGREE IN FLEXION, -50 DEGREE IN EXTENSION AND 20 DEGREE PRONO-SUPINATION. A CASE OF A (B)(6) YEAR OLD WITH DISTAL RADIUS FRACTURE HAD RADIOULNAR SYNOSTOSIS. HAD 65 SCORE IN MEPS, 85 DEGREE FLEXION, 0 EXTENSION, AND 0 PRONO-SUPINATION. A CASE OF A (B)(6) YEAR OLD HAD BRACHIAL PLEXUS INJURY. A CASE OF A (B)(6) YEAR OLD HAD RADIOULNAR SYNOSTOSIS. HAD 30 SCORE IN MEPS, 80 DEGREE IN FLEXION, 0 EXTENSION AND 180 PRONO-SUPINATION. A CASE OF A (B)(6) YEAR OLD HAD NON-UNION. HAD 30 SCORE IN MEPS , 80 DEGREE IN FLEXION, 0 EXTENSION, AND 0 PRONO-SUPINATION. A CASE OF A (B)(6) YEAR OLD RADIOULNAR SYNOSTOSIS, RADIAL NERVE INJURY .HAD 60 SCORE IN MEPS, 95 FLEXION ,-35 EXTENSION AND 115 PRONO-SUPINATION. A CASE OF (B)(6) YEAR OLD HAD RADIOULNAR SYNOSTOSIS. HAD 75 SCORE IN MEPS, 110 FLEXION, 0 EXTENSION AND 0 PRONO-SUPINATION. A CASE OF A (B)(6) YEAR OLD HAD ULNAR ARTERY INJURY EXTENSOR AND FLEXOR MUSCLES INJURY/LOSS OF FOLLOW A CASE OF A (B)(6) YEAR OLD HAD NON-UNION AND ELBOW STIFFNESS ELBOW STIFFNESS. A CASE OF A (B)(6) YEAR OLD HAD RADIAL ULNAR SYNOSTOSIS. HAD 55 SCORE IN MEPS,90 DEGREE FLEXION,0 EXTENSION, AND 10 PRONO-SUPINATION. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 3 SEPARATE COMPLAINTS (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREWS. IT CAPTURES A CASE OF A (B)(6) YEAR OLD WITH DISTAL RADIUS FRACTURE TREATED WITH LOCKING COMPRESSION PLATE OR LOW-CONTACT DYNAMIC COMPRESSION PLATES WHO HAD RADIOULNAR SYNOSTOSIS. HAD 65 SCORE IN MEPS, 85 DEGREE FLEXION, 0 EXTENSION, AND 0 PRONO-SUPINATION. THIS IS REPORT 8 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414056 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention