MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION; STANDARD CERVICAL PLATE

Model Number	UM102-02-34
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported that post-op x-rays revealed a screw is backing out from the plate, indicating that the plate's blocking mechanism may not have functioned as intended.No revision surgery has occured.

• Brand Name: UNION
• Common Device Name: STANDARD CERVICAL PLATE
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• MDR Report Key: 7373828
• Report Number: 3005823819-2018-00001
• Device Sequence Number: 2311880
• Product Code: KWQ
• UDI-Device Identifier: 00814386020145
• UDI-Public: 00814386020145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: UM102-02-34
• Device Catalogue Number: UM102-02-34
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1