MAUDE Adverse Event Report: ZIMMER VIRAGE OCT SPINAL FIXATION SYSTEM

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/27/2016

Event Type  Injury  

Event Description

Patient was treated with zimmer virage oct (occipital cervical thoracic) spinal fixation system to fuse cervical spine to occiput.Closure caps of device loosened and dislodged without trauma or physical mechanism.Surgery was performed on (b)(6) 2016.On (b)(6) 2016, cervical x-ray images demonstrated the above mentioned defect.Dates of use: (b)(6) 2016.Diagnosis or reason for use: cervical fxs.

• Brand Name: VIRAGE OCT SPINAL FIXATION SYSTEM
• Type of Device: VIRAGE OCT SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 5573453
• MDR Text Key: 42608531
• Report Number: MW5061657
• Device Sequence Number: 1
• Product Code: NKG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2016

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 65