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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TITANIUM ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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TITANIUM ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Break (1069)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Event Date 12/31/2017
Event Type  Injury  
Event Description
Fell in bathroom on (b)(6) 2017 and broke right femur. Had surgery (b)(6) 2018. A titanium rod was placed in leg to assist in supporting bone and aid in healing. I underwent very involved schedule of therapy for approx 2-3 months. At a point of about 3 months, leg began to hurt and was unbearable to put weight on it. Upon going for checkup appt early, dr reported the rod had broken into two. Dr referred me to a trauma surgeon specialist. Numerous xrays were done and indicated a second very involved surgery was required. Stainless steel plate and other hardware was placed during (b)(6) 2018 surgery. Again it required extensive inpatient rehab. Leg is responding and have been putting weight as tolerated. Would appreciate any assistance in what i need to do as this process has been unreal. Mfr name, city and state: would have to get from hospital. Thank you.
 
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Brand NameTITANIUM ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
MDR Report Key8080243
MDR Text Key128078381
Report NumberMW5081431
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/15/2018 Patient Sequence Number: 1
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