BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIC-DISTRACT R W/ADJUST-ANGLE

    MDR report key: 3173971 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03420
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    September 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED CERVICAL DISTRACTOR HAS SHOWN THAT ONE ARM IS INDEED MISSING A PIN AT THE JOINT OF THE FIXED ANGLE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN FELL OFF THE INSTRUMENT DURING A CERVICAL SURGERY. THE DISTRACTOR WAS USED AND DURING DISTRACTION, THE ARM FELL OFF. THE SMALL PIN THAT HOLDS IT ON TO THE DISTRACTOR IS GONE. AN MRI HAS BEEN DONE, BUT THE MISSING PIN WAS NOT FOUND. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273809 CERVIC-DISTRACT R W/ADJUST-ANGLE HWB SYNTHES GMBH T936459

    Patients

    Seq Age Sex Outcome Treatment
    1