BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5032578 · Received August 26, 2015

    Report

    Report Number
    2520274-2015-15208
    Event Type
    Injury
    Date Received
    August 26, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS NIGLIS,L. ET AL. "CRITICAL ANALYSIS OF OLECRANON FRACTURE MANAGEMENT BY PRE-CONTOURED LOCKING PLATES". ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 101 201-207 (2015). UNKNOWN PRE-CONTOURED 3.5 LOCKING COMPRESSION PLATE (LCP®) /UNKNOWN LOT. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: NIGLIS, L., "ET AL":CRITICAL ANALYSIS OF OLECRANON FRACTURE MANAGEMENT BY PRE-CONTOURED LOCKING PLATES. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 101 201-207 (2015). PATIENTS FROM SEPTEMBER 2009 TO DECEMBER 2011, 28 PATIENTS WITH COM-PLEX OLECRANON FRACTURES WERE MANAGED USING A PRE-CONTOURED 3.5MM LOCKING PLATES (LCP). OF THE 28 PATIENTS WITH COMPLEX FRACTURES, 6 WERE EXCLUDED BECAUSE OF MISSING DATA. TWENTY-TWO PATIENTS WERE STUDIED, 11 MALES AND 11 FEMALES WITH A MEAN AGE OF 55.7 YEARS (RANGE, 18-88 YEARS; MEDIAN, 59.5 YEARS). ALL 22 PATIENTS WERE RE-EVALUATED, AFTER A MEAN FOLLOW-UP OF 20 MONTHS. FRACTURE HEALING WAS OBTAINED IN ALL PATIENTS, AFTER A MEAN OF 10.6 WEEKS (RANGE, 6-20 WEEKS). THE POSTOPERATIVE RADIOGRAPHS INDICATED SATISFACTORY REDUCTION IN 19 PATIENTS. THE REMAINING 3 PATIENTS HAD A STEP-OFF OF AT LEAST 2 MM. NO METAPHYSEAL ABNORMALITIES IN THE SAGITTAL PLANE, PARTICULARLY IN FLEXION, WERE FOUND. NONE OF THE PATIENTS EXPERIENCED WORSENING OF REDUCTION IMPERFECTIONS OR SECONDARY DISPLACEMENT. AT RE-EVALUATION, 6 PATIENTS HAD EVIDENCE OF OSTEOARTHRITIS, WHICH WAS STAGE I IN 5 PATIENTS AND STAGE II IN 1 PATIENT, AFTER A MEAN FOLLOW-UP OF 23 MONTHS(RANGE, 13-40 MONTHS), WITH A SOMEWHAT UNSATISFACTORY CLINICAL OUTCOME IN A SINGLE CASE (PATIENT #11) AND NO EVIDENCE OF INADEQUATE ARTICULAR-SURFACE REDUCTION. OSSIFICATIONS DEVELOPED IN 3 PATIENTS, IN THE TRICEPS IN 1 CASE AND ABOUT THE JOINT IN 2, WITH NO CLINICAL CONSEQUENCES. FOREARM SYNOSTOSIS WAS FOUND IN 1 PATIENT (#17) AND TREATED DURING FIXATION MATERIAL REMOVAL, WITH A SATISFACTORY CLINICAL OUTCOME AT RE-EVALUATION. SIX COMPLICATIONS WERE RECORDED, INCLUDING COMPLEX REGIONAL PAIN SYNDROME IN 2 PATIENTS AND SPONTANEOUS EXTERIORISATION OF THE PINS THROUGH THE SKIN IN 2 PATIENTS. IN 1 PATIENT (#1), EARLY SCAR DEHISCENCE WAS BELIEVED TO INDICATE INFECTION AND WAS MANAGED BY SURGICAL REVISION ON DAY 14 FOR LAVAGE AND DEBRIDEMENT. THE BACTERIOLOGICAL SAMPLES WERE POSITIVE FOR ENTEROBACTER CLOACAE. THE OUTCOME WAS FAVOURABLE. IN 1 PATIENT (#3) A PRESSURE SORE DEVELOPED AFTER 16 MONTHS OVER THE PLATE, REQUIRING REMOVAL OF THE FIXATION MATERIAL FOLLOWED BY SUCTION NEGATIVE-PRESSURE DRESSINGS. THE OUTCOME WAS FAVOURABLE WITHOUT FURTHER SURGERY. THE FIXATION MATERIAL WAS REMOVED IN 6 (27%) PATIENTS, AFTER A MEAN OF 15.3 MONTHS. THE REASON FOR REMOVAL WAS MECHANICAL DYSFUNCTION CAUSED BY THE MATERIAL IN 5 PATIENTS (INCLUDING 2 WITH PROMINENCE OF THE TIP OF THE OLECRANON AND 1 WITH DISTAL PROMINENCE OF THE PLATE) AND A PRESSURE SORE IN 1 PATIENT. REMOVAL OF THE MATERIAL WAS NOT ASSOCIATED WITH ANY COMPLICATIONS. THIS REPORT IS FOR AN UNKNOWN PRE-CONTOURED 3.5 LOCKING COMPRESSION PLATE (LCP TM A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 4 OF 11 FOR COMPLAINT COM-(B)(4). THIS REPORT IS FOR THE SERIOUS INJURY OF 1 PATIENT THAT EXPERIENCED: FEMALE, (B)(6) YRS, COMPLEX REGIONAL PAIN SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565215 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention