BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7922169 · Received October 1, 2018

    Report

    Report Number
    2939274-2018-54007
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    September 5, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES DISTAL HUMERUS LOCKING COMPRESSION PLATES (LCP)/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER¿S PHONE NUMBER NOT PROVIDED FOR REPORTING. (B)(4). 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. 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: SHANNON, STEVEN, ET AL. (2018), OSTEOSYNTHESIS OF AO/OTA 13-C3 DISTAL HUMERAL FRACTURES IN PATIENTS OLDER THAN 70 YEARS, JOURNAL OF SHOULDER AND ELBOW SURGERY VOLUME 27, ISSUE 2, FEBRUARY 2018, PAGES 291-297. (USA). THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE CLINICAL OUTCOMES AND COMPLICATIONS OF OUR ELDERLY PATIENTS WITH ARBEITSGEMEINSCHAFT FÜR OSTEOSYNTHESEFRAGEN / ORTHOPEDIC TRAUMA ASSOCIATION (AO/OTA ) 13-C3 DISTAL HUMERAL FRACTURES SURGICALLY TREATED WITH OSTEOSYNTHESIS. BETWEEN 2007-2014, THERE WERE 16 PATIENTS OLDER THAN 70 YEARS WITH AO/OTA 13-C3 DISTAL HUMERAL FRACTURES WERE TREATED WITH OPEN REDUCTION INTERNAL FIXATION (ORIF) AND WITH GREATER THAN 1 YEAR OF FOLLOW-UP, WERE INCLUDED IN THE STUDY. ALL PATIENTS WERE IMPLANTED WITH SYNTHES DISTAL HUMERAL COLUMNAR PLATES WHICH WERE THE LOCKING COMPRESSION PLATES. BICOLUMNAR PLATING WAS USED IN 14 PATIENTS, WITH THE LATERAL COLUMN RECEIVING THE SYNTHES PRECONTOURED DISTAL HUMERAL POSTEROLATERAL LOCKING PLATE AND THE MEDIAL COLUMN RECEIVING EITHER THE SYNTHES PRECONTOURED DISTAL HUMERAL MEDIAL LOCKING PLATE (N = 6) OR THE SYNTHES 3.5-MM LOCKING RECONSTRUCTION PLATE (N = 8), WITH AT LEAST TWO BICORTICAL SCREWS IN EACH COLUMN PLATE. THE REMAINING PATIENTS RECEIVED A SINGLE LATERAL COLUMN SYNTHES POSTEROLATERAL LOCKING PLATE WITH MEDIAL PINS (N = 1) AND A POSTEROLATERAL LOCKING PLATE (N = 1). THE MEAN AGE WAS 78 (70-84) YEARS. THERE WAS AN EQUAL DISTRIBUTION OF WOMEN (N = 8) AND MEN (N = 8). PRIMARY OUTCOMES, SUCH FRACTURE HEALING, AS SEEN ON RADIOGRAPHS; QUICK DISABILITIES OF THE ARM, SHOULDER, AND HAND (QUICKDASH) SCORE; MAYO ELBOW PERFORMANCE SCORE (MEPS); AND COMPLICATIONS WERE THEN RECORDED AND ASSESSED. THE FOLLOWING COMPLICATIONS WERE REPORTED: THREE PATIENTS DIED BEFORE ONE YEAR FOLLOW-UP. AN (B)(6) NONSMOKER WITH A HISTORY OF HYPERTENSION AND DYSLIPIDEMIA, PRESENTED AT 31 MONTHS WITH CLINICAL, RADIOGRAPHIC, AND LABORATORY FINDINGS OF CHRONIC OSTEOMYELITIS. THE PATIENT UNDERWENT SURGICAL DÉBRIDEMENT WITH REMOVAL OF REMAINING IMPLANTS AND PLACEMENT OF ANTIBIOTIC BEADS FOR 48 HOURS WITH SUBSEQUENT REMOVAL AND PRIMARY CLOSURE. A (B)(6) NONSMOKER WITH A HISTORY OF HYPERTENSION, PRESENTED WITH PARTIAL WOUND DEHISCENCE AT 2 WEEKS AND UNDERWENT IRRIGATION, DÉBRIDEMENT, AND PRIMARY CLOSURE WITH NO REMOVAL OF HARDWARE AND WAS DISCHARGED HOME THE SAME DAY. THE PATIENT WAS PRESCRIBED ORAL TRIMETHOPRIMSULFAMETHOXAZOLE AND MOXIFLOXACIN. AT 18 WEEKS, THE PATIENT PRESENTED WITH REDNESS, SWELLING, AND ELEVATED INFLAMMATORY MARKERS, SUBSEQUENTLY UNDERGOING SURGICAL DÉBRIDEMENT AND REMOVAL OF IMPLANTS WITH PRIMARY WOUND CLOSURE. A (B)(6) FEMALE PATIENT UNDERWENT REMOVAL OF A SYMPTOMATIC OLECRANON SCREW WITH TENSION BAND WIRE AT 6 MONTHS FROM INITIAL SURGERY. THIS REPORT IS FOR (B)(6) PATIENT WHO UNDERWENT IRRIGATION AND DEBRIDEMENT FOR A PARTIAL WOUND DEHISCENCE. THE PATIENT UNDERWENT A 2ND DEBRIDEMENT AND REMOVAL OF IMPLANTS. THIS REPORT IS FOR UNKNOWN SYNTHES DISTAL HUMERUS LOCKING COMPRESSION PLATES (LCP). THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762640 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention