MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG OBELSIC; CENTER PIECE 20MM, HEIGHT 32-47MM, TWO VARIABLE END

Model Number	CS 2920-32
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user had difficulty attaching the left side of the obelisc end piece to the center cage.This resulted in an approximately 1.5 hours of additional operating time.

• Brand Name: OBELSIC
• Common Device Name: CENTER PIECE 20MM, HEIGHT 32-47MM, TWO VARIABLE END
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 11358200
• Report Number: 9612420-2021-00004
• Device Sequence Number: 4117530
• Product Code: MQP
• UDI-Device Identifier: 04052536005598
• UDI-Public: 04052536005598
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CS 2920-32
• Device Catalogue Number: CS 2920-32
• Device Lot Number: U028450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/22/2021
• 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