MAUDE Adverse Event Report: ULRICH MEDICAL USA SOLIDITY; CENTER PIECE, TURQUOISE, DIA 13MM, HEIGHT 19-27.5MM

Model Number	UU041-01-1927
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a post operative follow up, the vbr cage previously implanted had become loose after a surgical washout was conducted.The cage was removed and replaced with a larger one.Collapse or subsidence was not reported.There was no effect on the patient other than the unexpected delay.

• Brand Name: SOLIDITY
• Common Device Name: CENTER PIECE, TURQUOISE, DIA 13MM, HEIGHT 19-27.5MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 23393375
• Report Number: 3005823819-2025-00014
• Device Sequence Number: 18628338
• Product Code: MQP
• UDI-Device Identifier: 00814386022293
• UDI-Public: 00814386022293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: UU041-01-1927
• Device Catalogue Number: UU041-01-1927
• Device Lot Number: U033971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 77 YR
• Patient Sex: Female