BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4216721 · Received October 31, 2014

    Report

    Report Number
    2520274-2014-14207
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    June 17, 2012
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. TREATMENT OF NEER TYPE II FRACTURES OF THE LATERAL CLAVICLE USING DISTAL RADIUS LOCKING PLATES COMBINED WITH TIGHTROPE AUGMENTATION OF THE CORACO-CLAVICULAR LIGAMENTS. HOHMANN, E., HANSEN, T., TETSWORTH, K. ARCH ORTHOP TRAUMA SURG. (2012). THIS REPORT IS FOR AN UNKNOWN 2.4 MM VOLAR DISTAL RADIUS LOCKING PLATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, TREATMENT OF NEER TYPE II FRACTURES OF THE LATERAL CLAVICLE USING DISTAL RADIUS LOCKING PLATES COMBINED WITH TIGHTROPE AUGMENTATION OF THE CORACO-CLAVICULAR LIGAMENTS. HOHMANN, E., HANSEN, T., TETSWORTH, K. ARCH ORTHOP TRAUMA SURG. (2012) 132:1415-1421. BETWEEN 2007 AND 2010, A TOTAL OF 31(23 MALES, 8 FEMALES) WITH A NEER TYPE II FRACTURES WERE MANAGED OPERATIVELY AT OUR INSTITUTION. THE PURPOSE OF THE STUDY WAS TO REVIEW THE CLINICAL OUTCOME OF NEER TYPE II LATERAL CLAVICLE FRACTURES TREATED USING A NOVEL TECHNIQUE, WHICH INCORPORATES A SUPERIORLY PLACED DISTAL RADIUS LOCKING PLATE COMBINED WITH TIGHTROP¿ FIXATION THROUGH THE BASE OF THE CORACOID PROCESS TO AUGMENT THE CORACO-CLAVICULAR LIGAMENTS. CLINICAL OUTCOME WERE ASSESSED USING THE SPADI, DASH, CONSTANT AND TAFT SCORES. SUBJECTS WERE EVALUATED AT 6 WEEKS, 3, 6 MONTHS, AND 1 YEAR AND EXCELLENT SHOULDER FUNCTION WITH A LOW COMPLICATION RATE. COMPLICATION: PATIENT NO. 20- PRESENTED 6 MONTHS AFTER SURGERY WITH A NON-UNION AND HARDWARE FAILURE REQUIRING RE-PLATING AND BONE GRAFTING, AND UNION WAS SUBSEQUENTLY ACHIEVED 9 WEEKS LATER. IT IS UNCLEAR IF THE SYNTHES DEVICE OR THE COMPETITOR'S DEVICE WAS THE CAUSE OF THE COMPLICATION OF NON-UNION AND HARDWARE FAILURE. THIS REPORT IS FOR AN UNKNOWN 2.4 MM VOLAR DISTAL RADIUS LOCKING PLATE. THIS IS REPORT 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700127 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention