MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.This report is for an unknown axon system/unknown lot/quantity unknown.Additional device code: kwp.(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.

Event Description

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.Us article.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 one patient who required return to the operating room for errant lateral mass screw placement (malposition), with no subsequent sequelae following revision fixation.This report is for an unknown axon system.This is report 2 of 2 for complaint (b)(4).

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6447355
• MDR Text Key: 71323777
• Report Number: 2520274-2017-11126
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention