MAUDE Adverse Event Report: SYNTHES USA TI VECTRA(TM) PLATE 1 LEVEL/14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Break (1069)

Patient Problems Dysphagia/ Odynophagia (1815); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation; 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.(b)(4).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.(b)(4).

Event Description

This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.This is report 1 of 1 for (b)(4).

• Brand Name: TI VECTRA(TM) PLATE 1 LEVEL/14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 5547201
• MDR Text Key: 41863999
• Report Number: 2520274-2016-11958
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: PK050451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/05/2016
• 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