BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX CROSS CONNECTOR,5.5,TI, MED, SIZE A7

    MDR report key: 3934531 · Received July 15, 2014

    Report

    Report Number
    1526439-2014-11685
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    June 20, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MNH
    PMA / PMN Number
    PK062196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIZE A7 5.5MM TI MEDIAL SERIES CROSS CONNECTOR (PRODUCT CODE: 1894-01-407, LOT NUMBER: MC5707) WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) ON SEPTEMBER 30TH, 2014 AFTER THE INITIAL CLOSURE OF THE COMPLAINT. BOTH OF THE SET SCREWS FEATURED IN THE INSTRUMENT THAT HOLD DOWN ITS ¿FEET¿ FOR HOLDING THE ROD IN PLACE ARE MISSING. NO DAMAGE IS FEATURED AROUND WHERE THEY SHOULD BE, SO IT IS NOT BELIEVED THAT THEY WERE FORCED OUT. IT MERELY APPEARS AS IF THEY WERE REMOVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE WAS PERFORMED. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS SUCH, PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A TRENDING ANALYSIS WAS CONDUCTED. NO SYSTEMIC TRENDS WERE FOUND. A ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. REQUESTS FOR FURTHER INFORMATION HAVE NOT RECEIVED A RESPONSE. IT IS POSSIBLE THAT THE CONNECTOR SET SCREWS WERE DAMAGED INTRA-OPERATIVELY OR THAT THE SETSCREWS WERE MISSING, THOUGH PER THE DHR NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE SFX CROSS CONNECTOR DID NOT HAVE THREADS TO TIGHTEN A CONCOMITANT DEVICE ROD. ANOTHER CROSS CONNECTOR WAS USED TO COMPLETE THE PROCEDURE WITH NO RESULTING DELAY. A REQUEST WAS MADE TO THE AFFILIATE FOR CLARIFICATION TO DETERMINE IF THREADS WERE TORN FROM THE CROSS CONNECTOR¿S SET SCREW COMPONENT INTRA-OPERATIVELY. AS THE REQUESTED INFORMATION HAS NOT BEEN PROVIDED TO DATE AND IT IS NOT KNOWN IF THREADS WERE TORN FROM THE SET SCREW COMPONENT INTRA-OPERATIVELY, THE MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412869 SFX CROSS CONNECTOR,5.5,TI, MED, SIZE A7 ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH DEPUY SYNTHES SPINE MC5707

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD, CATALOG NO. UNKNOWN