MAUDE Adverse Event Report: SYNTHES, USA; BONE PLATE

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown matrixmandible plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown matrixmandible plate.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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

It was reported that the arch bar bent and the right mandibular arch bar screws came out of a matrixwave maxillomandibular fixation (mmf) system on an unknown date postoperatively.The system was originally implanted on (b)(6) 2016 during an open reduction and internal fixation (orif) due to bilateral mandible body fractures, severely displaced on the right.The patient was noted to have an open bite at the clinic and then presented to the emergency department with hardware malfunction; the right mandibular arch bar screws came out when he was eating mashed potatoes and the arch bar was bent.The bent portion of the arch bar was removed in the emergency department.On (b)(6) 2016 the patient underwent arch bar removal with plan for likely orthognathic surgery one year post injury.This report is for one (1) unknown matrixmandible plate.This is report 1 of 2 for com-(b)(4).

• Type of Device: BONE PLATE
• 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: 6406155
• MDR Text Key: 70003063
• Report Number: 2520274-2017-10883
• Device Sequence Number: 1
• Product Code: JEY
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• 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
• Patient Age: 23 YR