MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG OBELSIC; CENTER PIECE 20MM, HEIGHT 76-132MM, TWO VARIABLE END

Model Number	CS 2920-76
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Obelisc attachment plate detached post-operatively.Report 1 of 3.

• Brand Name: OBELSIC
• Common Device Name: CENTER PIECE 20MM, HEIGHT 76-132MM, TWO VARIABLE END
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 11924587
• Report Number: 9612420-2021-00005
• Device Sequence Number: 3179288
• Product Code: MQP
• UDI-Device Identifier: 04052536005628
• UDI-Public: 04052536005628
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: CS 2920-76
• Device Catalogue Number: CS 2920-76
• Device Lot Number: U019144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 06/02/2021
• 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: Hospitalization