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

Model Number	UM102-03-57
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a union screw began to back out of the plate.It is unsure whether the locking mechanism was actuated or not.The patient experienced pain, leading to an mri scan (mri images are unavailable).However, an image was shared, showing one of the locking mechanism tabs appears to be broken, allowing the screw to back out.A revision surgery was performed and the union plate was removed.As of 19 march 2025, the plate has not been returned for evaluation.

• Brand Name: UNION CPS
• Common Device Name: STANDARD CERVICAL PLATE
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074
• MDR Report Key: 21667717
• Report Number: 3005823819-2025-00005
• Device Sequence Number: 8180248
• Product Code: KWQ
• UDI-Device Identifier: 00814386020251
• UDI-Public: 00814386020251
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150666
• Exemption Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: Health Professional
• Device Model Number: UM102-03-57
• Device Catalogue Number: UM102-03-57
• Device Lot Number: U012909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American