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Model Number S7
Device Problem Imprecision (1307)
Patient Problems Perforation (2001); Iatrogenic Source (2498)
Event Date 10/08/2014
Event Type  Injury  
Manufacturer Narrative
Patient age and sex were not made available. This number addresses the 9 males and 8 females in this study. The median age was 47. 6 years (range 22-78 years). Patient weight was not provided by the journal article surgeon/author. The event was reported to have occurred from, august 2011 to august 2013, when the cervical fixation procedures were completed. The article was accepted on 10/8/2014. Further information was not provided by the authors. Francesco costa, md, alessandro ortolina, md, luca attuati, md, andrea cardia, md, massimo tomei, md, marco riva, md, luca balzarini, md, and maurizio fornari, md. Management of c1¿2 traumatic fractures using an intraoperative 3d imaging¿based navigation system. J neurosurg spine (2015). Http://thejns. Org/doi/abs/10. 3171/2014. 10. Spine14122 the journal article's discussion states that, "one of the most common causes of inaccuracy is dictated by the positioning of the frame of the navigation system. When fixed to a spinous process (we usually avoid the c-2 spinous process), it is possible that the frame will move. Fixation of the reference frame directly to the mayfield clamp, as adopted by other authors, may avoid its mobilization, but this can lead to difficulties in visualization of the frame by the navigation system camera due to the presence of the surgeon. Another common cause of inaccuracy in cases involving a traumatic fracture is the mobility of bone fragments, which leads to c-1 and c-2 instability that can cause variations of the anatomy with respect to the 3d images reconstructed by the navigation system. " the instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy. If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result. ¿ and ¿warning: do not bump or reposition the reference frame after registration. Such movement may result in inaccurate navigation. If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister. " the journal article confirms: in summary, spinal navigation in the management of c1¿2 fractures is a feasible and safe technique when performed using the imaging system. However, even if great effort is made to achieve good results with the imaging system, we want to stress that this technology cannot completely eliminate all risks associated with spinal instrumentation, and the experience and skill of the surgeons remain essential determining factors. Customer has not requested service for the system regarding this event. No parts have been returned for analysis.
Event Description
A medtronic representative reported an event that was identified in journal article. Fractures of c-1 and c-2 are complex and surgical management may be difficult and challenging due to the anatomical relationship between the vertebrae and neurovascular structures. The aim of this study was to evaluate the role, reliability, and accuracy of cervical fixation using the imaging system intraoperative 3d image¿based navigation system. The article states that a screw perforation between 2-4mm in the cranio-caudal direction occurred during one (1. 5%) c-2 trauma procedure with patient number 4, using the navigation system. The article states that this error was due to the mobilization of the passive frame during surgery. This screw was changed and the reposition was graded as 0. No major cortical violation was observed. No intraoperative complications such as injury of the va, spinal nerve root, or spinal cord was recorded. Other patient events mentioned in the article are reported in mdr 1723170-2016-05791, 1723170-2016-05792, 1723170-2016-05793, 1723170-2016-05794 and 1723170-2016-05796.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6171557
MDR Text Key62282712
Report Number1723170-2016-05795
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/13/2016 Patient Sequence Number: 1