BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8599390 · Received May 10, 2019

    Report

    Report Number
    8030965-2019-63753
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    April 12, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    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 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. (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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: P. JUNGBLUTH ET. AL (2018), THE CHALLENGE OF MONTEGGIA-LIKE LESIONS OF THE ELBOW, THE BONE AND JOINT JOURNAL, VOL.100B(2), PAGES 212-218 (GERMANY) DOI: 10.1302/0301-620X.100B2.BJJ-2017-0398.R2. THE AIM OF THIS ARTICLE IS TO EVALUATE MID-TERM RESULTS OF THE OPERATIVE TREATMENT OF MONTEGGIA-LIKE LESIONS AND TO DETERMINE THE PROGNOSTIC FACTORS THAT INFLUENCE THE CLINICAL AND RADIOLOGICAL OUTCOME. BETWEEN 2005 TO 2014, A TOTAL OF 46 PATIENTS (19 MALE AND 27 FEMALE) WITH A MEAN AGE OF 55.7 YEARS (RANGE, 18 ¿ 84 YEARS) WERE INCLUDED IN THE STUDY. WHO UNDERWENT SURGERY FOR A MONTEGGIA-LIKE LESION WERE THE ULNA WAS FIXED USING A PROXIMALLY CONTOURED SYNTHES LCP AND LCP OLECRANON PLATE WERE 5 PATIENTS WERE TREATED WITH AN ADDITIONAL HINGED ELBOW SYNTHES FIXATOR. THE MEAN DURATION OF FOLLOW-UP WAS 65.3 MONTHS (RANGES 27 - 111). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS UNDERWENT IRRIGATION AND DEBRIDEMENT BECAUSE OF AN EARLY WOUND INFECTION. 4 PATIENTS NEEDED BONE GRAFTING AND REVISION PLATING DUE TO NONUNION OF THE ULNA. FOLLOWING WHICH UNION PROGRESSED UNREMARKABLY. 1 PATIENT WITH AN ASSOCIATED INJURY OF THE INTEROSSEOUS MEMBRANE, WITH SECONDARY PROXIMAL RADIAL SHIFT. 2 ELDERLY PATIENTS WITH NONUNION OF THE ULNA, WHICH REQUIRED SECONDARY BONE GRAFTING AND REVISION PLATING. THIS REPORT IS FOR UNKNOWN SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393714 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention