BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L40 T

    MDR report key: 3143279 · Received June 3, 2013

    Report

    Report Number
    2530088-2013-00857
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. THE VISUAL INSPECTION REVEALED THE GOLD PART OF THE SCREW WAS DAMAGED. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LED TO THIS REPORTED PROBLEM. IT IS POSSIBLE THAT TOO MUCH MECHANICAL FORCE WAS APPLIED DURING THE REMOBILIZATION AND MAY HAVE CAUSED THE SEPARATION OF THE COMPONENTS. ANOTHER POSSIBLE REASON FOR SUCH AN OCCURRENCE COULD BE THAT SCREW HEAD BLOCKED AFTER INSERTION AND WITH THE ALIGNMENT TOOL ATTEMPTS TO ALIGN THE SCREW MAY HAVE STRIPPED THE SCREW HEAD. REVIEWING THE MANUFACTURING- AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INDETERMINATE. PLACEHOLDER.

    Description of Event or Problem · 1

    THE GOLD PART OF THE SCREW DAMAGED. DURING SURGERY AFTER ALIGNMENT WITH THE ALIGNMENT TOOL, THE DOCTOR NOTICED THAT THE GOLD PART OF THE SCREW WAS PROTRUDING. THE SCREW BROKE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244404 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L40 T NKB SYNTHES BRANDYWINE 6569495

    Patients

    Seq Age Sex Outcome Treatment
    1