MAUDE Adverse Event Report: ULRICH GMBH & CO. KG OBELISC; LOCKING SCREW

Model Number	CS 2901
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/09/2015
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 report is being submitted past 30 day deadline based on retrospective review conducted 6/21/2019.Original mdr (report 1 of 2) filed 10/07/2015.
Event or Problem Description
A revision surgery was required to remove obelisc vbr cage due to unintended cage retraction.We did not receive the devices back and could not determine whether the cage or set screw caused the event.Report 2/2.

• Brand Name: OBELISC
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8745556
• Report Number: 9612420-2019-00014
• Device Sequence Number: 11272604
• Product Code: MQP
• UDI-Device Identifier: 04052536005567
• UDI-Public: 4052536005567
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K060416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019
• Report Date (Section F): 09/09/2015

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 2901
• Device Catalogue Number: CS 2901
• Device Lot Number: U000518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2015
• Device Age: 4 YR
• Date Report to Manufacturer: 09/09/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2015
• Initial Report FDA Received Date: 06/28/2019
• 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: 35 YR