MAUDE Adverse Event Report: SYNTHES (USA) VECTRA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 04.613.014

Device Problem Material Fragmentation (1261)

Patient Problems Abscess (1690); Purulent Discharge (1812); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930)

Event Date 02/10/2016

Event Type  Injury  

Event Description

Vectra plates placed in patient at c5 and c6 approximately 10 months ago.The event involves a 14 mm synthes vectra plate that was implanted in the patient.She did well initially but developed dysphagia and presented to the ed with severe dysphagia approximately 2 months ago.Ct of the neck revealed a retropharyngeal abscess around two tiny metallic objects of which one was retrieved at surgery.It is believed that this retrieved metallic fragment originated from one of the locking flanges of the vectra plate.Approximately 3 days later, she was transferred to higher level of care for repair of the pharyngeal-esophageal opening.The surgical incision made and large amount of purulent drainage present; removed with a 22 gauge needle.Purulent material was removed from retropharyngeal space.Previously placed vectra plate removed.Underneath the plate a small foreign body was found and removed.This foreign body was metallic in nature.Drainage and foreign body sent for culture; came back positive for prevotella oris beta lactamase, prevotella melaninogenica beta lactamase, streptococcus mitis/oralis, and streptococcus salivarius subspecies.

• Brand Name: VECTRA
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES (USA); 1303 goshen pkwy; west chester PA 19380
• MDR Report Key: 5503540
• MDR Text Key: 40517027
• Report Number: 5503540
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 04.613.014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention