BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-WEDGE OPENING WEDGE BONE LOCKING SYSTEM

    MDR report key: 2982669 · Received February 25, 2013

    Report

    Report Number
    3004993707-2013-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    June 25, 2012
    Report Date
    February 19, 2013
    Manufacturer
    RAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA)
    Product Code
    HRS
    PMA / PMN Number
    K111326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE SCREW WAS AVAILABLE FOR EVALUATION. ONLY A PORTION OF THE BROKEN SCREW COULD BE EVALUATED. EVALUATION SUMMARY: TESTING WAS NOT PERFORMED ON THE SCREW, ONLY A PORTION OF THE SCREW WAS RETURNED. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PORTION OF THE SCREW USING 5X MAGNIFICATION AND CALIPERS AND REVEALED THAT BREAK OCCURRED AT .221/.241" (ANGLED) FROM THE TOP OF THE HEAD. THE VISUAL INSPECTION DID NOT REVEAL A KNOWN CAUSE FOR THE SCREW TO BREAK. A REVIEW OF THE MANUFACTURING PAPERWORK (DEVICE RECORDS) REVEALED THAT THE PROCESSES WERE MET ACCORDING TO DRAWING SPECIFICATIONS HELD IN THE DEVICE MASTER RECORD. A REVIEW OF OUR INSPECTION PAPERWORK ALSO CONFIRMED THAT THE MFG. PROCESSES WERE MET ACCORDING THE DEVICE MASTER RECORD. AN INCOMPLETE DEVICE WAS RETURNED AND THE CAUSE OF THE FAILURE WAS NOT FOUND. GRAMEDICA RECEIVED THE DEVICE IN A CONDITION MAKING A THOROUGH EVALUATION IMPOSSIBLE. FOR METALLIC INTERNAL FIXATIONS DEVICES THIS IS A KNOWN POTENTIAL RISK, AND STATED ON OUR PACKAGE INSERT, INSTRUCTIONS FOR USE REV. 1. GRAMEDICA HAS REDUCED THIS POTENTIAL RISK BY PERFORMING MECHANICAL TESTS ON THE SCREWS PER (B)(4) FROM A MEDIUM RISK LEVEL TO A LOW RISK LEVEL.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PERSISTENT/CONSTANT PAIN, LEADING TO THE DISCOVERY OF THE BROKEN SCREW. REMOVAL WAS PERFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80771 OSTEO-WEDGE OPENING WEDGE BONE LOCKING SYSTEM BONE LOCKING PLATE SYSTEM HRS RAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA) GM-200-14 14656-030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention