BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 6.35 TI SI SETSCREW

    MDR report key: 4090194 · Received September 15, 2014

    Report

    Report Number
    1526439-2014-11901
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK062174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPEDIUM 6.35 SETSCREW WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SET SCREW ROD SHOWED STANDARD SIGNS OF ROD CONTACT STRIATIONS. NO DAMAGE OR ANY OTHER ANOMALIES WERE IDENTIFIED. THE EXACT LOT NUMBER OF THE 1 SETSCREW THAT WAS REPORTED TO BE LOOSE IS UNKNOWN. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD (DHR) ON THE ADDITIONAL SET SCREW LOTS IDENTIFIED FOUND NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS. THE ROOT CAUSE OF THE DEVICE BECOMING LOOSE CANNOT BE POSITIVELY DETERMINED HOWEVER A POSSIBLE ROOT CAUSE MAY BE THAT THE DEVICES WERE NOT FULLY TIGHTENED TO THE INTENDED TORQUE LEVEL, RESULTING IN THE SETSCREW AND ROD LOOSENING. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    THE SET SCREW WAS RETURNED AND THE COMPLAINT HAS BEEN REOPENED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    THE SET SCREW WAS NOT RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE UNKNOWN SET SCREW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE UNKNOWN SET SCREW AND COULD NOT BE CONDUCTED AS NO PRODUCT CODES OR PRODUCT FAMILIES WERE KNOWN. WITHOUT THE RETURNED OF THE DEVICES IN QUESTION OR INFORMATION ABOUT THE PRODUCT CODE TO FAMILY WE ARE UNABLE TO CONFIRM THE REPORTED ISSUES OR IDENTIFY THE ROOT CAUSE. THIS COMPLAINT FILE IS BEING CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLES BE PROVIDED, THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED BY COMPLAINANT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE PATIENT COMPLAINED ABOUT IMPLANTS. SHE FELT THAT SOMETHING WAS LOOSE, AND SHE WANTED ILIAC SCREWS AT S2 TO BE REMOVED FOR HER COMFORT. REVISION SURGERY FOUND ONE ROD WAS LOOSE. IT IS NOT KNOWN IF THE ROD LOOSENING WAS ATTRIBUTED TO THE ROD OR A SET SCREW THAT SECURED IT I PLACE. ILIAC SCREWS WERE REMOVED ACCORDING TO THE PATIENT¿S DESIRE BUT WITH NO INDICATION OF FAILURE. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE ROD AND SET SCREW WHICH WERE INVOLVED IN THIS EVENT: 1526439-2014-11900, 1526439-2014-11901.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568330 EXPEDIUM 6.35 TI SI SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention ILIAC SCREWS| RODS X 3