BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HWC

    MDR report key: 8513753 · Received April 15, 2019

    Report

    Report Number
    8030965-2019-62799
    Event Type
    Injury
    Date Received
    April 15, 2019
    Report Date
    March 21, 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 LOCKING SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN LOCKING SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). 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: SERRANO-MATEO, L. ET AL (2014), RESULTS AFTER INTERNAL FIXATION OF HUMERUS DISTAL FRACTURES IN PATIENTS AGED OVER 65 YEARS, REVISTA ESPAÑOLA DE CIRUGÍA ORTOPÉDICA Y TRAUMATOLOGÍA, VOL. 58 (1), PAGES 31-37 (SPAIN). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE RADIOLOGICAL AND FUNCTIONAL RESULTS OF OPEN REDUCTION AND INTERNAL FIXATION FOR PATIENTS AGED MORE THAN 65 WHO HAD SUFFERED DISTAL HUMERUS FRACTURE (SUPRACONDYLAR AND SUPRA INTERCONDYLAR HUMERUS). A TOTAL OF 24 PATIENTS (83% WAS FEMALE) WHO WERE TREATED BY OPEN REDUCTION AND INTERNAL FIXATION BETWEEN THE YEARS 2005 AND 2010 WERE INCLUDED IN THE STUDY. ALL THE PATIENTS UNDERWENT POSTERIOR SURGICAL APPROACH USING SYNTHES LOCKING COMPRESSION PLATES (LCP) AND UNKNOWN SYNTHES RECONSTRUCTION PLATES. THE MEAN AGE OF THE GROUP WAS 76.8 YEARS (65---89). THE MEAN FOLLOW-UP WAS 42 MONTHS (FROM 15 MONTHS TO 7 YEARS). THE ARTICLE DID NOT SPECIFY WHAT IMPLANTS WERE ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS. 2 CASES OF NON-UNION (DISTAL HUMERUS IN ONE PATIENT AND OLECRANON OSTEOTOMY IN ANOTHER). 2 CASES OF SURGICAL WOUND INFECTION. 3 COMPLICATIONS DERIVED DIRECTLY FROM PROBLEMS WITH THE OSTEOSYNTHESIS MATERIAL(BREAK OR MIGRATION). 2 OF THESE COMPLICATIONS (2 CASES OF ULNAR NERVE NEUROPRAXIA) WERE MINOR (1 REMOVAL OF A TENSION BAND AND 1 OF A STEM) DUE TO MIGRATION WITHOUT AFFECTING THE COURSE OR THE NATURAL DEVELOPMENT OF THE FRACTURE, WHILE THE OTHER COMPLICATION (1 CASE OF RADIAL NERVE NEUROPRAXIA) REQUIRED A NEW SYNTHESIS/REOSTEOSYNTHESIS DUE TO DISPLACEMENT FROM INSUFFICIENT INITIAL FIXATION (SINGLE POSTERIOR PLATE). 2 DEATHS LOST TO FOLLOW-UP DUE TO CAUSES UNRELATED TO THE FRACTURE. THIS REPORT IS FOR AN UNKNOWN SYNTHES LOCKING SCREWS. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306925 HWC HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention