BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3996490 · Received August 8, 2014

    Report

    Report Number
    1526439-2014-11733
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN SCREW. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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: LOCKED PATING OF THE PROXIMAL HUMERUS USING AN ENDOSTEAL IMPLANT. CAROLYN M. HETTRICH, ET AL. (2012) JOURNAL OF ORTHOPEDIC TRAUMA 26:212-215. THIS WAS A (B)(4) STUDY THAT INCLUDED THE CHART REVIEW OF 31 PATIENTS WITH PROXIMAL HUMERUS FRACTURES AND WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH ENDOSTEAL AUGMENTATION BETWEEN (B)(6) 2006 AND (B)(6) 2008. THE PURPOSE OF THE STUDY WAS TO REPORT ON THE USE OF A SUPPLEMENTAL MEDIAL ENDOSTEAL IMPLANT TO PREVENT VARUS COLLASPE AND SCREW CUTOUT PROXIMAL HUMERUS FRACTURES TREATED WITH A LATERALLY PLACED LOCKING PLATE. OF THE 31 PATIENTS, 4 PATIENTS WERE LOST TO FOLLOW-UP. OF THESE 4 PATIENTS, 2 DIED OF UNRELATED CAUSES BEFORE THE 6 MONTH FOLLOW-UP PERIOD. THE MEAN AGE OF PATIENTS WAS 65 +/- 9.9 YEARS OLD AND THE AVERAGE FOLLOW-UP WAS 63.1 WEEKS. A 3.5-MM LCP PROXIMAL HUMERUS PLATE (SYNTHES, (B)(4)) WITH A MEDIAL ENDOSTEAL IMPLANT (BIBULAR ALLOGRAFT IN 23 PATIENTS AND SEMITUBULAR PLATE IN 4 PATIENTS) WERE USED FOR FIXATION. TWENTY-SIX OF THE 27 PATIENTS MAINTAINED THEIR ORIGINAL REDUCTION WITH AN AVERAGE LOSS OF HEIGHT OF 1.2 MM AND AND AN AVERAGE CHANGE IN SHAFT-HEAD ANGLE BY 2.2 DEGREES. THERE WERE NO IMPLANT FAILURES OR SCREW PERFORATIONS OF THE ARTICULAR SURFACE AND NO RADIOGRAPHIC OR CLINICAL EVIDENCE OF AVASCULAR NECROSIS (AVN). IN THE 27 PATIENTS WITH COMPLETE FOLLOW-UP, 1 PATIENT HAD AN INFECTION. THERE WERE NO IDENTIFIABLE PATIENTS. THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466869 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention