BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3982271 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12513
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. KOBAYASHI, M., WATANABE, Y., AND MATSUSHITA, T. (2010). EARLY FULL RANGE OF SHOULD AND ELBOW MOTION IS POSSIBLE AFTER MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES. JOURNAL ORTHOPAEDIC TRAUMA 24(4) 212-216. THIS REPORT IS FOR AN UNKNOWN LCP PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. KOBAYASHI, M., WATANABE, Y., AND MATSUSHITA, T. (2010). EARLY FULL RANGE OF SHOULD AND ELBOW MOTION IS POSSIBLE AFTER MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES. JOURNAL ORTHOPAEDIC TRAUMA 24(4) 212-216. THE OBJECTIVE OF THE STUDY WAS TO MEASURE THE SPEED OF FULL SHOULDER AND ELBOW RANGE OF MOTION RECOVERY FOLLOWING MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) FOR HUMERAL SHAFT FRACTURES. FROM MARCH 2005 TO JULY 2007, 14 CONSECUTIVE PATIENTS WITH CLOSED HUMERAL SHAFT FRACTURES UNDERWENT SURGERY BY A SINGLE SURGEON. THE MIPO TECHNIQUE INVOLVED PROXIMAL DELTO-BICIPITAL INCISION AND DISTAL BRACHIALIS-SPLITTING INCISION. A NARROW LOCKING 4.5/5.0 MILLIMETER COMPRESSION PLATE WAS APPLIED PERCUTANEOUSLY ON THE ANTERIOR SURFACE OF THE HUMERUS. THE MEDIAN FOLLOW-UP TIME WAS 14 MONTHS (RANGE: 12¿21 MONTHS). THE MEDIAN OPERATION TIME WAS 117.5 MINUTES (RANGE: 70¿145 MINUTES), AND MEDIAN AMOUNT OF INTRAOPERATIVE BLOOD LOSS WAS 170.5 G (RANGE: 17¿373 G). IN ALL CASES, MAIN FRAGMENTS WERE REDUCED IN ANATOMICAL ALIGNMENT WITHOUT ANY ANGULAR DEFORMITY OR ANY TRANSLATION. ALL FRACTURES HAD UNEVENTFUL UNION WITH NO INFECTION OR WOUND COMPLICATION. ALL PATIENTS REGAINED NORMAL SHOULDER MOTION (180_ OF BOTH ABDUCTION AND FLEXION) AND NORMAL ELBOW MOTION (SAME AMOUNT OF BOTH EXTENSION AND FLEXION AS UNINJURED SIDE).MEDIAN TIME TO NORMAL MOTION RECOVERY WAS 19 DAYS (RANGE: 7¿159 DAYS) IN THE SHOULDER. THE 159-DAY OUTLIER WAS IN THE (B)(6) WOMAN WITH AN 18-DAY DELAY BETWEEN INJURY AND OPERATION. MEDIAN TIME TO NORMAL MOTION RECOVERY WAS 60 DAYS (RANGE: 7¿448 DAYS) IN THE ELBOW. THE 448-DAY OUTLIER IN THIS CASE WAS A TYPE B1 FRACTURE, WHERE THE PLATE HAD BEEN PLACED SO DISTALLY THAT ELBOW FLEXION WAS LIMITED DUE TO PLATE IMPINGEMENT WITH THE RADIAL HEAD. THE PLATE WAS REMOVED 7 MONTHS AFTER THE INDEX PROCEDURE, AND ELBOW MOTION RECOVERED TO NORMAL 8 MONTHS AFTER PLATE REMOVAL. NO OTHER CASES REQUIRED IMPLANT REMOVAL. THIS COMPLAINT IS FOR 1 DEVICE. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LCP PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456392 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention