BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 4343980 · Received December 18, 2014

    Report

    Report Number
    2520274-2014-15456
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ALL OF THE COMPLAINED SCREWS ARE: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS IN DIFFERENT LENGTHS WHICH WERE ADDED TO THE INFORMATION BELOW. SYNTHES CANNOT IDENTIFY HOW MANY OR WHICH OF THE SCREWS WERE LOOSE. THE COMPLAINANT REPORTED THE FOLLOWING SCREWS LISTED IN THE DEVICE HISTORY REPORTS (DHR) REVIEWS WITH A QUANTITY OF ONE SCREW FOR EACH PART. THE RESPECTIVE DEVICE HISTORY REPORTS HAVE BEEN RUN FOR ALL THE PARTS REPORTED WITH THE FOLLOWING RESULTS: NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION FOR ANY OF THE PARTS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCTS LISTED BELOW THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MANUFACTURING DATES AND MANUFACTURING LOCATIONS ARE IDENTIFIED BELOW: 412.117 / 8582256- LENGTH 40MM, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 26. AUG.2013. 412.114 / 1627580- LENGTH 35MM, MANUFACTURING LOCATION: (B)(4), SUPPLIER: KKS ULTRASCHALL ((B)(4)), MANUFACTURING DATE: 29. JAN.2007. 412.119 / 8708338- LENGTH 45MM, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 08. NOV.2013. 412.114 / 3048700- LENGTH 35MM, MANUFACTURING LOCATION: (B)(4), SUPPLIER: KKS ULTRASCHALL ((B)(4)), MANUFACTURING DATE: 11. DEC.2008. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE FOUR SUBJECT SCREWS. ALL FOUR SCREWS WERE VISUALLY INSPECTED AND FOUND TO BE IN GOOD CONDITION. AS PREVIOUSLY REPORTED, THERE WERE NO MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT OF POST-OPERATIVE LOOSENING. SINCE ADDITIONAL INFORMATION WAS NOT MADE AVAILABLE, A ROOT CAUSE COULD NOT BE DETERMINED. 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED APPROXIMATELY FOUR MONTHS POST-OPERATIVE THE PATIENT REPORTED PAIN. THE DOCTOR IDENTIFIED THE LOCKING SCREWS IN THE PLATE WERE LOOSED. THE SCREWS WERE REMOVED AND REPLACED. AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: I CAN CONFIRM LOOSENING AND BACK-OUT OF 3 SCREWS. REPORTEDLY THERE WERE NO SURGICAL DELAYS THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831957 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention