MAUDE Adverse Event Report: SYNTHES USA TI MULTI-VECTOR DISTRACTOR ARM75MM; SCREW FIXATION,INTRAOSSEOUS

Catalog Number 487.977

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported that a distractor on a mandible doesn't seem to be distracting at the same rate.Parents of the patient say that they distracted it and it feels like it distracted but that it's regressed back.During a follow up visit on (b)(6) 2015, it was noted that the distractor was working fine.At some point later, the surgeon thinks that there is potentially a functional issue with distractor.The exact functional issue is unknown.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Event date: unknown.Implant date: unknown.Device has not been reported as explanted 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.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.

• Brand Name: TI MULTI-VECTOR DISTRACTOR ARM75MM
• Type of Device: SCREW FIXATION,INTRAOSSEOUS
• 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: 4651345
• MDR Text Key: 20788066
• Report Number: 2520274-2015-12453
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 487.977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2015
• 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