BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3790026 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11210
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: THE CALCAR SCREW IN ANGULAR STABLE PLATE FIXATION OF PROXIMAL HUMERAL FRACTURES - A CASE STUDY. OSTERHOFF ET AL. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH 2011, 6:50. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR UNKNOWN SCREW. 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. THE CALCAR SCREW IN ANGULAR STABLE PLATE FIXATION OF PROXIMAL HUMERAL FRACTURES - A CASE STUDY; GEORG OSTERHOFF, CHRISTIAN OSSENDORF, GUIDO A WANNER, HANS-PETER SIMMEN AND CLÉMENT M WERNER. OSTERHOFF ET AL. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH 2011, 6:50. THIS IS A RETROSPECTIVE REVIEW OF THE CALCAR SCREW IN ANGULAR STABLE PLATE FIXATION OF PROXIMAL HUMERAL FRACTURES. A TOTAL OF 68 PATIENTS WITH PROXIMAL HUMERAL FRACTURE UNDERWENT ANGULAR STABLE PLATE FIXATION WITHIN THE OBSERVATION PERIOD. ONE PATIENT DIED SHORTLY AFTER SURGERY BECAUSE OF NON-RELATED DIAGNOSES. SIX PATIENTS WERE LOST TO FOLLOW-UP AS THEY DID NOT APPEAR AT THEIR OUTPATIENT CLINIC APPOINTMENTS FOR UNKNOWN REASONS. ONE PATIENT (GROUP C+) PRESENTED WITH AN EARLY WOUND INFECT WHICH MADE IT NECESSARY TO REMOVE THE PLATE JUST 13 DAYS POSTOPERATIVELY. THUS, FOLLOW-UP WAS POSSIBLE ONLY IN 60 PATIENTS. TWENTY-ONE PATIENTS FORMED GROUP C-. THIRTY NINE PATIENTS FORMED THE GROUP C+. HUMERAL HEAD NECROSIS OCCURRED IN 6 C+ AND 3 C- CASES. CUT-OUT OF THE PROXIMAL SCREWS WAS OBSERVED IN 3 C+ AND 1 C- CASES. IN EACH GROUP, 1 PATIENT SHOWED DELAYED UNION. IMPLANT FAILURE OR LESIONS OF THE AXILLARY NERVE WERE NOT OBSERVED. NO NEUROLOGICAL DEFICITS WERE OBSERVED IN GROUP C-, AND 2 PATIENTS IN GROUP C+ SHOWED NEUROLOGICAL DEFICITS. DUE TO THESE COMPLICATIONS, REVISION SURGERY WAS REQUIRED IN 6 C+ AND 4 C- PATIENTS. IN 44 PATIENTS, TRUE AP AND NEER VIEWS WERE AVAILABLE TO MEASURE THE HEAD-PLATE DISTANCE. THERE WAS A SIGNIFICANT LOSS OF REDUCTION IN GROUP C- COMPARED TO C+. THIS REPORT IS FOR UNKNOWN SCREW FOR HUMERAL NECROSIS (9 PATIENTS). THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269360 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention