BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3954527 · Received July 24, 2014

    Report

    Report Number
    0009617544-2014-00322
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; RESULTS: NO PRODUCT WAS IDENTIFIED EXCEPT THAT IT WAS A STRYKER SPINE PRODUCT. THE COMPLAINANT CLAIMED TO HAVE MUSCLE WEAKNESS AROUND THE ABDOMEN AND WAS REQUIRED TO WEAR A BRACE. THE COMPLAINANT STATED THAT HE HEARD A LECTURE BY A SURGEON THAT "OPEN SPINE SURGERIES CAUSE MORE HARM THAN GOOD" THAN DO MIS SPINE SURGERIES. THE COMPLAINANT FEELS THAT THERE IS NOT ENOUGH INFORMATION MADE AVAILABLE TO PATIENTS ABOUT THE DIFFERENCES BETWEEN OPEN AND MIS IMPLANTS. THE COMPLAINANT REFUSED TO ANSWER ANY MORE QUESTIONS AND NO FURTHER INFORMATION (PRODUCT TYPE, XRAYS, ETC.) IS AVAILABLE. CONCLUSION: INFORMATION IS AVAILABLE FROM STRYKER TO THE SURGEONS IN THE FORM OF IFUS AND SURGICAL TECHNIQUES. ULTIMATELY, THE SURGEON IS RESPONSIBLE FOR DETERMINING THE APPROPRIATE SPINAL PRODUCT BASED ON PATIENT ANATOMY, HEALTH, PATHOLOGY AND DESIRED OUTCOME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DOCTOR PREFORMED SPINE SURGERY IMPLANTING PINS AND RODS IN BACK ¿ ¿12 INCH¿ INCISION; PATIENT DOES NOT KNOW SPINE SEGMENTS ASSOCIATED WITH IMPLANT. HOWEVER, THE PATIENT CLAIMED THAT WITHIN MONTHS HIS ¿STOMACH MUSCLES WENT¿ AND NOW NEEDS TO WEAR ELASTIC BRACE AROUND STOMACH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DOCTOR PREFORMED SPINE SURGERY IMPLANTING PINS AND RODS IN BACK - "12 INCH" INCISION; PATIENT DOES NOT KNOW SPINE SEGMENTS ASSOCIATED WITH IMPLANT. HOWEVER, THE PATIENT CLAIMED THAT WITHIN MONTHS HIS "STOMACH MUSCLES WENT" AND NOW NEEDS TO WEAR ELASTIC BRACE AROUND STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433889 UNKNOWN_SPINE_PRODUCT UNKNOWN KWP STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other