BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5024635 · Received August 24, 2015

    Report

    Report Number
    2520274-2015-15320
    Event Type
    Injury
    Date Received
    August 24, 2015
    Report Date
    August 17, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. BAE, J., HAN, S., HUR, C., LIM, H., OH, J. (2009) ARTHRODESIS OF THE KNEE USING CANNULATED SCREWS. THE JOURNAL OF BONE AND JOINT SURGERY, 91-B(2), PP: 180-184. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE "THRODESIS OF THE KNEE USING CANNULATED SCREWS." BAE, J., HAN, S., HUR, C., LIM, H., OH, J. (2009). THIS PROSPECTIVE STUDY WAS UNDERTAKEN TO EVALUATE THE OUTCOME AFTER ARTHRODESIS OF THE KNEE USING CANNULATED SCREWS. 8 PATIENTS WERE INCLUDED IN THIS STUDY WHO UNDERWENT ARTHRODESIS OF THE KNEE USING CANNULATED SCREWS (SYNTHES, PAOLI, PENNSYLVANIA) BETWEEN 1998 AND 2005 WERE EVALUATED. THERE WERE SIX WOMAN AND TWO MEN WITH AN AGE 36 TO 76 YEARS. PRIMARY UNION WAS ACHIEVED IN SEVEN PATIENTS. AT A MEAN FOLLOW-UP OF 5.8 YEARS ALL PATIENTS WERE ABLE TO WALK WITHOUT PAIN AND NONE HAD EVIDENCE OF INSTABILITY OR RECURRENT INFECTION. DELAYED UNION OCCURRED IN ONE PATIENT WITH SEVERE BONE LOSS WHO UNDERWENT A FURTHER BONE GRAFTING PROCEDURE SIX MONTHS AFTER THE INITIAL OPERATION. UNION WAS ACHIEVED TWO MONTHS LATER. ONE PATIENT HAD NECROSIS OF THE WOUND MARGINS AND REQUIRED SKIN GRAFTING. THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557609 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention