MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Extrusion (2934)

Patient Problems Failure of Implant (1924); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Fountas, k.N., kapsalaki, e., machinis, t., liipfert, r., smisson, h.(2007).Salvage of a failed odontoid screw.Journal of clinical neuroscience, pp.484-488.Report is for an unknown cannulated screw.Udi #: unknown part number, udi unavailable.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.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 the subsequent review of the following literature article: fountas, k.N., kapsalaki, e., machinis, t., liipfert, r., smisson, h.(2007).Salvage of a failed odontoid screw.Journal of clinical neuroscience, pp.484-488.United states.The purpose of the article, was to examine a case of the complications associated with anterior odontoid screw fixation.The case involved a 71 year old caucasian male with a type ii odontoid fracture who underwent anterior screw fixation at the c5-c6 level using a synthes lag, cannulated screw (4.0mm diameter, 42mm length).Approximately 4 weeks postoperatively, the patient presented with dysphagia and cervical spine x-rays and ct scans revealed the crew had backed out 12mm off the c2 vertebral body.The patient underwent revision surgery to remove the implanted screw and implant a new 4.0mm x 46mm cannulated screw.Follow-up examinations at 6, 12, and 18 months included x-rays and clinical examination and showed no screw extrusion.This is report 1 of 1 for (b)(4).This report is for an unknown cannulated screw.This report is related to: device failure (backout, extrusion), revision of internal fixation, removal of internal fixation, dysphagia, neck pain.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Gender, male.Race - white.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5429840
• MDR Text Key: 37967790
• Report Number: 2520274-2016-10968
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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
• Patient Age: 71 YR