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 Code	Failure of Implant (1924)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
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 or screw may have been over-angulated.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: 7490355
• Report Number: 3005823819-2018-00003
• Device Sequence Number: 11097693
• Product Code: KWQ
• UDI-Device Identifier: 00814386020145
• UDI-Public: 00814386020145
• Combination Product (Y/N): N
• PMA/510(K) Number: K150666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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
• 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: 04/08/2018
• Initial Report FDA Received Date: 05/07/2018
• 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: Other
• Patient Age: 64 YR