BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE

    MDR report key: 3203812 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-04045
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND IN SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE PROVIDED DETAILS WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIAL STRUCTURE, WHICH INDICATES MATERIAL CONFORMITY AS WELL. PATIENT HISTORY RECEIVED FROM THE (B)(4) ON NOVEMBER 14TH, 2013 CONFIRMING MULTIPLE SURGERIES WITH FAILED FUSIONS. PATIENT HISTORY RECEIVED FROM (B)(4) DATED (B)(6) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.H11 CORRECTED DATA:EVENT WAS INCORRECTLY REPORTED AS A PRODUCT PROBLEM ON FOLLOW UP #2, THE EVENT WILL BE CONSIDERED AN ADVERSE EVENT AS INITIALLY REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: MNI, MNH, KWP, KWQ. DEVICE RETURNED FOR EVALUATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE REMOVAL, A BROKEN ROD AND BROKEN SCREW WERE FOUND. THIS WAS A PLANNED REMOVAL OF INSTRUMENTATION FROM T12 TO THE PELVIS. THE PATIENT HAD A BROKEN ROD ON THE LEFT SIDE AND A BROKEN PELVIC SCREW ON THE RIGHT ILIAC WING. ALL INSTRUMENTATION WAS REMOVED WITH NO ISSUES. THE SURGEON USED A MIDAS CUTTING BURR TO CUT THE RODS BELOW THE T11 PEDICLE SCREWS. THE MATERIAL WAS NOT RECEIVED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR A FOR A T1 POLYAXIAL HEAD FOR USS POLYAXIAL. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR UNIVERSAL SPINAL SYSTEM (USS)-II POLYAXIAL 3D-HEAD. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304526 USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE NKB SYNTHES GMBH 3342914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention