MAUDE Adverse Event Report: ZAVATION, LLC ZAVATION, LLC; 4-LEVEL CERVICAL PLATE

Model Number	30-0460
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Complaint description - tab broke from locking cam which allowed screw to back out.Surgeon elected to remove screw as fusion was solid.Revision surgery was completed with no known complications.Surgeon elected to remove only the 1 screw as fusion was solid.Therefore we are unable to determine the definitive cause of issue.

• Brand Name: ZAVATION, LLC
• Common Device Name: 4-LEVEL CERVICAL PLATE
• Manufacturer (Section D): ZAVATION, LLC; 220 lakeland parkway; flowood MS 39232
• MDR Report Key: 6665335
• Report Number: 3008583793-2017-00003
• Device Sequence Number: 10966793
• Product Code: KWQ
• UDI-Device Identifier: 00842166105607
• UDI-Public: 00842166105607
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Physician
• Device Model Number: 30-0460
• Device Lot Number: Z0404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention