MAUDE Adverse Event Report: ULRICH GMBH & CO. KG OBELISC VERTEBRAL BODY REPLACEMENT; OBSELISC CENTER PIECE, DIAMETER 20MM

Model Number	CS 2920-32
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
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
Implant failure after spondylodesis after lwk2 on lwk4 with secondary dislocation of the inserted obelisc pro cage after lwk3 fracture.A piece of the obelisc cage broke off and the cage was removed in a revision surgery.

• Brand Name: OBELISC VERTEBRAL BODY REPLACEMENT
• Common Device Name: OBSELISC CENTER PIECE, DIAMETER 20MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8465476
• Report Number: 9612420-2019-00008
• Device Sequence Number: 11169859
• Product Code: MQP
• UDI-Device Identifier: 04052536005598
• UDI-Public: 4052536005598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: Health Professional
• Device Model Number: CS 2920-32
• Device Catalogue Number: CS 2920-32
• Device Lot Number: U007151
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/29/2019
• 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 Age: 22 YR