MAUDE Adverse Event Report: MEDTRONICS ATLANTIS ANTERIOR CERVICAL IMPLANT; ATLANTIS CERVICAL IMPLANT

Lot Number ATLANTIS ANTERIOR

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Choking (2464)

Event Type  Injury  

Event Description

Few days after cervical implant by medtronic with bone implant, i was unable to walk for 2 to 3 days.It is unheard of in medical profession the high doses of morphine and oxycodone i was on after surgery.Severe pain in neck, shoulders, hands, my legs.The surgeon told me this was permanent and would not be removed.In january, medtronics told me this was not meant to be permanent implant.I suffer from claustrophobia since all mri.Never know when i can raise by head or someone else has to before i can move.Severe panic attacks due to choking.

• Brand Name: ATLANTIS ANTERIOR CERVICAL IMPLANT
• Type of Device: ATLANTIS CERVICAL IMPLANT
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 5380600
• MDR Text Key: 36494256
• Report Number: MW5059409
• Device Sequence Number: 1
• Product Code: KWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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 Lot Number: ATLANTIS ANTERIOR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 75