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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Shatsky, j., bellabarba, c., nguyen, q., and bransford, r.J.(2016).A retrospective review of fixation of c1 ring fractures¿does the transverse atlantal ligament (tal) really matter? the spine journal, 16, 372-379 brand name: this report is for an unknown axon system/unknown lot/quantity unknown.Additional device code: kwp.(other number) udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This report is being filed after subsequent review of the following journal article.Shatsky, j., bellabarba, c., nguyen, q., and bransford, r.J.(2016).A retrospective review of fixation of c1 ring fractures¿does the transverse atlantal ligament (tal) really matter? the spine journal, 16, 372-379.A retrospective review of all patients with c1 fractures between september 2002 and september 2013 was performed, delineating all patients that had undergone c1 open reduction and internal fixation (orif) without fusion.Patients were included in the series if they had undergone orif for acute, unstable c1 ring fracture.Polyaxial 3.5-mm screws (axon, synthes) were placed into the bilateral lateral masses of c1.The polyaxial screw caps were then locked to allow lateral to medial compression of each lateral mass to facilitate c1 ring reduction by preventing screw toggle.A 3.5-mm titanium rod was molded into a bowed contour.The rod was used to assist with reduction and was placed transversely between the two c1 screws.Lateral compression was accomplished with a compressive device between the two c1 lateral mass screws.Final tightening of the construct was performed with the goal of achieving symmetric compression of the fracture.Postoperatively, all patients underwent ct scan imaging to assess the accuracy of screw placement and adequacy of reduction.Anteroposterior, lateral, and open mouth odontoid view x-rays were obtained until 3 months.At 3 months, dynamic flexion and extension radiographs were obtained to evaluate c1¿c2 instability.A total of 12 patients underwent primary orif for c1 fractures without fusion between september 2002 and september 2013.The mean age of the cohort was 43, with a maximum age of 86 and a minimum age of 21.There were nine males and three females.Mean follow-up was 17.3 months.One patient was completely lost to follow-up after leaving the hospital in a stable condition.One patient died of injuries sustained in his accident unrelated to the spine.Two complications were documented to have occurred in the 12 patients.This medwatch refers to the patient who was noted to have occipital¿c1 arthrosis.This is hypothesized to be secondary to avascular necrosis (avn) of the c1 lateral mass.The patient was noted to have abnormally hard bone during the procedure.The ct scan at 3 months illustrated healed fracture with collapse of one of the lateral masses and arthrosis of the occipital¿c1 joints.The patient ultimately had removal of his hardware at the 4-month mark.This report is for an unknown axon system.This is report 1 of 2 for complaint (b)(4).A copy of the journal article is being submitted with this medwatch.
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Search Alerts/Recalls
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