MAUDE Adverse Event Report: ULRICH GMBH & CO. KG OBELISC; OBELISC CENTER PIECE 20MM, HEIGHT 76-132MM

Model Number	CS 2920-76
Medical Device Problem Codes	Collapse (1099); Structural Problem (2506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer) exemption # e2014011.
Event or Problem Description
Based on patient x-ray, surgeon believes the obelisc cage collapsed approximately 4mm.It is hard to determine from the angle of the x-ray at 9 months versus the post-op x-ray whether the cage has collapsed or how this could have happened.According to the surgeon, the patient is doing very well and experiencing no pain or discomfort.No serious injury occured.It is inconclusive whether the cage has collapsed.

• Brand Name: OBELISC
• Common Device Name: OBELISC CENTER PIECE 20MM, HEIGHT 76-132MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6504699
• Report Number: 9612420-2017-00013
• Device Sequence Number: 13397
• Product Code: MQP
• UDI-Device Identifier: 04052536005628
• UDI-Public: 4052536005628
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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 2920-76
• Device Catalogue Number: CS 2920-76
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/19/2017
• 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