MAUDE Adverse Event Report: SYNTHES USA; EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for two unknown internal distractors/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 the subsequent review of the following literature article: van sickels, joseph e., mathew j.Madsen, larry l.Cunningham, and douglas bird."the use of internal maxillary distraction for maxillary hypoplasia: a preliminary report." american association of oral and maxillofacial surgeons: 1715-720.Web.Usa.Over a 5-year period, more than 300 patients with craniofacial and dentofacial defects have undergone oral and maxillofacial surgery at our center to correct their skeletal discrepancies.Of these, 10 have had maxillary distraction osteogenesis done with internal distractors (synthes, (b)(4)).Follow-up of 6 months or more was available for 8 patients.One patient had an unrepaired palate with a large fistula.She had been referred from an alternate service for distraction to decrease the size of the fistula.The proposed plan was to narrow the fistula and correct the maxillary hypoplasia.The size of the fistula was decreased, but control of the 2 freely movable segments was difficult and the maxilla was not advanced the desired amount.This report 1 of 3 for (b)(4).This report is for unknown internal distractors.

• Type of Device: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
• 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: 5506997
• MDR Text Key: 40548639
• Report Number: 2520274-2016-11651
• Device Sequence Number: 1
• Product Code: MQN
• 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
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• 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: 03/04/2016
• 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