MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 976-142

Device Problem Insufficient Information (3190)

Patient Problem Vertigo (2134)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies recieved.Hence, we cannot come to a conclusion yet.

Event Description

It was reported as per the patient, she knew that she had metal allergies before the surgery was performed, but the doctors told her it was not something to be concerned about.Since she had the surgery, she swelled at the base of her skull.She sometimes lost feeling on the right side of her face.She also suffered from vertigo.She was in horrible pain and sometimes it was so bad that it caused her to be sick.She had her blood tested for metal poisoning.It did confirm her allergies, but she doesn't recall what they were.She gave the list to her doctors and now she needed to know the metal composition of her 3 implants so that she could take the information to her doctors and they could decide if the items should be removed.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5020809
• MDR Text Key: 23679169
• Report Number: 1030489-2015-02030
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Report Date: 07/24/2015

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: Health Professional
• Device Catalogue Number: 976-142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other