MAUDE Adverse Event Report: ULRICH GMBH & CO. KG OBELISC; OBELISC CENTER PIECE, 20MM, HEIGHT 40-62MM

Model Number	CS 2920-40
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Cage migrated post-op.

• Brand Name: OBELISC
• Common Device Name: OBELISC CENTER PIECE, 20MM, HEIGHT 40-62MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 14311196
• Report Number: 3005823819-2022-00012
• Device Sequence Number: 5313960
• Product Code: MQP
• UDI-Device Identifier: 04052536005604
• UDI-Public: 04052536005604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022
• Report Date (Section F): 05/05/2022

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
• Device Model Number: CS 2920-40
• Device Catalogue Number: CS 2920-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 05/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2022
• 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: Required Intervention
• Patient Sex: Unknown