MAUDE Adverse Event Report: SYNTHES USA; INSTRUMENT, BENDING OR CONTOURING

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/07/2015

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following abstract: "plate exposure after anterolateral thigh free-flap reconstruction in head and neck cancer patients with composite mandibular defects" (2015).Fanzio p.M.Et al.Taiwan article.Between january 2007 and june 2012, 1,452 patients who underwent free tissue transfer after head and neck cancer ablation were retrospectively reviewed.The study focused on the predictive risk of plate exposure.The study enrolled 123 men and 7 women.A titanium mandibular reconstruction system (synthes, inc., (b)(4)) was used to bridge the mandibular defects.Out of 123 men, post-operative plate exposure occurred for 49 men (age range - 55.3 ± 10.0) and 74 men (age range - 56.7 ± 13.6) had no post - operative plate exposure.36 patients with non exposed plates developed post operative wound infection and 21 patients with exposed plates developed post operative wound infection.This is report 1 of 1 for (b)(4).This report is for unknown (cmf) mandibular reconstruction system.A copy of the journal article is being submitted with this medwatch.This report is for 1 device.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: "plate exposure after anterolateral thigh free-flap reconstruction in head and neck cancer patients with composite mandibular defects" (2015).Fanzio p.M.Et al.Taiwan article.This report is for an unknown mandibular reconstruction system / unknown quantity / unknown lot.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.

• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• 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: 4551089
• MDR Text Key: 15119667
• Report Number: 2520274-2015-11217
• Device Sequence Number: 1
• Product Code: HXP
• 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,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• 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?: No
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention