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

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Device used for treatment not diagnosis jeong, d., you, n., lee, c., cho, k., kim, s.(2013) posterior c2-c3 fixation for unstable hangman¿s fracture.Korean j spine 10 (3): 165-9, 2013 (korea).This report is for an unknown synapse system screw / unknown quantity / unknown lot 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 subsequent review after the subsequent review of the following literature article: jeong, d., you, n., lee, c., cho, k., kim, s.(2013) posterior c2-c3 fixation for unstable hangman's fracture.Korean j spine 10 (3): 165-9, 2013 (korea).This is a retrospective review of 13 unstable hangman's fractures who underwent posterior c2-3 fixation to describe clinical outcomes with a literature review.Thirteen consecutive patients with unstable hangman's fracture underwent posterior c2-c3 fixation using the polyaxial screw-rod synapse system.Thirteen patients, 8 men and 5 women with mean age of 43, with unstable hangman's fracture were enrolled between july 2007 and june 2010 were included in this study.The medical records of all patients were reviewed.Concurrently, clinical outcomes were evaluated using neck disability index scores and visual analogue scale scores during preoperative and postoperative follow up period.Serial radiographs were done to assess bone fusion.This report 1 of 1 for (b)(4).This report is for an unknown synapse system screw complication: one patient underwent revision surgery due to screw malposition, loosening.This report is for 1 of 1 device.

Manufacturer Narrative

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.

• Type of Device: ORTHOSIS, SPINAL PEDICLE
• 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: 5215010
• MDR Text Key: 30972136
• Report Number: 2520274-2015-17080
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• 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