BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIST ARTHRODESIS NAIL SYSTEM (IMPLATE)

    MDR report key: 4148909 · Received October 1, 2014

    Report

    Report Number
    MW5038485
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    November 21, 2013
    Report Date
    October 1, 2014
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN ORTHOPEDIC SURGEON INSTALLED A SKELETAL DYNAMICS IMPLATE/WRIST ARTHRODESIS NAIL ON (B)(6) 2012. THE SAME ORTHOPEDIC SURGEON BELIEVED THAT THE IMPLATE HAD FAILED AND DETERMINED EXPLANTATION WAS NECESSARY. SKELETAL DYNAMICS WAS NOTIFIED OF THE FAILURE ON (B)(6) 2013. SKELETAL DYNAMICS MADE NO REQUEST TO HAVE THE IMPLATE RETAINED FOR FURTHER INSPECTION. THE SAME ORTHOPEDIC SURGEON EXPLANTED THE SKELETAL DYNAMICS IMPLATE ON (B)(6) 2013. THE OPERATIVE REPORT INCLUDED THE FOLLOWING EXCERPTS. "AS I OPENED UP THE JOINT CAPSULE, THE IMPLANT WAS EASILY IDENTIFIED AND WAS FOUND TO BE LOOSE. THE 2 LOCKING SCREW IN THE IMPLANT TO THE CONNECTOR WERE LOOSE. THE INTRAMEDULLARY NAIL IN THE THIRD METACARPAL WAS ALSO LOOSE. (PT) DID HAVE METALLOSIS NOTED IN THE SOFT TISSUES". THE HEALTH FACILITY THAT PURCHASED AND APPROVED THE USE OF THE SKELETAL DYNAMICS IMPLATE DENIED THE PTS REQUEST TO HAVE THE DEVICE RETAINED AND INSPECTED. SKELETAL DYNAMICS WAS NOTIFIED, BY THE PT, ON (B)(6) 2013. SKELETAL DYNAMICS THEN PROCEEDED TO FILE AN MDR. SKELETAL DYNAMICS PROVIDED THE FOLLOWING STATEMENT FOR THE MFR NARRATIVE, "CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA". SKELETAL DYNAMICS FAILED TO RESPOND TO PT'S CORRESPONDENCE. SKELETAL DYNAMICS PROVIDED THE FOLLOWING STATEMENT FOR THE EVENT DESCRIPTION, "IT WAS REPORTED THAT DEVICE WAS REMOVED. IT ALSO WAS REPORTED THAT PT HAD WORK RELATED INJURY, PRIOR SURGERY AND DEVELOPMENT OF SIGNIFICANT PHYSIOLOGICAL CHANGES PRIOR TO DEVICE IMPLANT PROCEDURE". SKELETAL DYNAMICS PROVIDED THIS STATEMENT WITHOUT A HIPPA RELEASE AND IN POSSESSION OF OPERATIVE REPORT(S). THERE HAS NEVER BEEN A DETERMINATION OR STATEMENT MADE BY THE ORTHOPEDIC SURGEON OR ANY OTHER MEDICAL PROFESSIONAL THAT THERE WAS/HAS BEEN A SIGNIFICANT PHYSIOLOGICAL CHANGE. SKELETAL DYNAMIC FABRICATED THE STATEMENT FOR THEIR BENEFIT. FOLLOWING THE EXPLANTATION SURGERY, THERE HAS BEEN AN IMPAIRMENT RATING ISSUED FOR THE RIGHT UPPER EXTREMITY. THE SKELETAL DYNAMICS MDR DATED (B)(6) 2013 DEVICE EVENT KEY (B)(4) MDR REPORT KEY (B)(4), EVENT KEY (B)(4), REPORT NUMBER 3006742481-2013-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610466 WRIST ARTHRODESIS NAIL SYSTEM (IMPLATE) NONE HSB SKELETAL DYNAMICS AZ0311001
    610517 WRIST ARTHRODESIS NAIL SYSTEM (IMPLATE) NONE HSB SKELETAL DYNAMICS AZ1110010

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| O| R