BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-LINK-CLAMP F/R Ø6 PREASSMBL TAN DB

    MDR report key: 3170001 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03310
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    October 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS DETERMINATION HAS BEEN REVISED AFTER INFORMATION WAS RECEIVED THAT THE PRODUCT WAS NOTICED TO BE DEFECTIVE BY THE AFFILIATE IN THE WAREHOUSE. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE ALLEGED MALFUNCTION OF CLAMP COULD NOT MOVE LED TO A SERIOUS INJURY OR DEATH. INJURY OR DEATH DUE TO THE RECURRENCE OF THIS DESCRIBED EVENT IS REMOTE. THE PRODUCT WAS NOT USED ON A PATIENT AND WAS NOT IN A FACILITY TO BE USED. THIS IS NOT AN FDA REPORTABLE EVENT. PLACEHOLDER.

    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL AND PERFORMANCE TESTING OF THE COMPLAINED CLAMP HAS SHOWN THAT THIS ARTICLE DOES NOT COMPLY WITH OUR SPECIFICATIONS: THE SET SCREW WAS MOUNTED INCORRECTLY. A CAPA DETERMINATION HAS BEEN REQUESTED. THE COMPLAINT IS DETERMINED TO BE VALID.

    Description of Event or Problem · 1

    CROSS LINK CLAMP COULD NOT MOVE. THIS IS 6 OF 13 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270435 CROSS-LINK-CLAMP F/R Ø6 PREASSMBL TAN DB NKB SYNTHES GMBH 2781162

    Patients

    Seq Age Sex Outcome Treatment
    1