MAUDE Adverse Event Report: SYNTHES (USA) TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT/20MM; BONE PLATE

Catalog Number 487.962

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the footplate of the vector distractor disengaged prematurely resulting in revision surgery.Initially, the surgeon used proplan to plan for mandible distractor (ramus).The plan was to distract the patient for about 15 months.Piezo osteotomies were performed.A single vector distractor (20 mm) was applied to patient¿s right mandible on (b)(6) 2015.The surgeon waited five days before beginning the planned distraction rate of 1 mm/day.The patient came in for follow up examination (date unknown) and the surgeon took an x-ray and noticed very little distraction had occurred to date.The x-ray seemed to show possible disengagement of the distractor body from the proximal foot plate.The surgeon removed the vector distractor device on (b)(6) 2015.It was reported that it appears the proximal footplate disengaged prematurely.The surgeon used the piezoelectric system to make sure the osteotomy did not consolidate.The surgeon put on a multi-vector distractor and will distract at a rate of 1mm/day until desired objectives are achieved (15mm-20mm).The patient is reported to be doing well.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight was not provided by reporter.Date of event is not applicable.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Event Description

Additional information received.It was reported that the patient came in for a follow up on (b)(6) 2015.The surgeon noticed that there was minimal distraction that had occurred.The surgeon brought the patient to the operating room (or) for an evaluation under anesthesia (eua) on (b)(6) 2015.The surgeon tested the device and found that the device is working properly.The surgeon also found that the pin placement and purchase were very good.It was concluded by the surgeon that the patient's mother was most likely not activating the device properly and believes that the patient's mother was not putting the linear activation instrument completely on the distraction nut to turn the device.The surgeon reviewed this information with the patient's mother.The surgeon will distract the patient 1.5 mm/day for about one week to complete the distraction.

• Brand Name: TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT/20MM
• Type of Device: BONE PLATE
• 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: 4723507
• MDR Text Key: 18931709
• Report Number: 2520274-2015-13370
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK022005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 487.962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• 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