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

Model Number	UU041-01-1927
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
6 week post-op x-rays show vbr height reduction.

• Brand Name: SOLIDITY
• Common Device Name: CENTER PIECE, TURQUOISE 13MM, HEIGHT 19-27.5MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• MDR Report Key: 9526656
• Report Number: 3005823819-2019-00013
• Device Sequence Number: 16838521
• Product Code: MQP
• UDI-Device Identifier: 00814386022293
• UDI-Public: 00814386022293
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: UU041-01-1927
• Device Catalogue Number: UU041-01-1927
• Device Lot Number: U019367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 10/29/2021
• 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: 38 YR