MAUDE Adverse Event Report: ZAVATION, LLC ZAVATION; CERVICAL PLATE - 1 LEVEL

Model Number	30-0112
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Locking plate spun while trying to lok screw in place.

• Brand Name: ZAVATION
• Common Device Name: CERVICAL PLATE - 1 LEVEL
• Manufacturer (Section D): ZAVATION, LLC; 220 lakeland parkway; flowood MS 39232
• MDR Report Key: 6461580
• Report Number: 3008583793-2017-00001
• Device Sequence Number: 608793
• Product Code: KWQ
• UDI-Device Identifier: 00842166105300
• UDI-Public: 00842166105300
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/08/2017

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: No Information
• Device Model Number: 30-0112
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/07/2017
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other