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

Model Number	CS 8010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
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 7) filed 6/2/2017.
Event or Problem Description
Screws and locking screws were getting threads damaged on final tightening.Report 4/7.

• Brand Name: FLAMENCO
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8745541
• Report Number: 9612420-2019-00018
• Device Sequence Number: 2039976
• Product Code: MNI
• UDI-Device Identifier: 04052536021369
• UDI-Public: 4052536021369
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019
• Report Date (Section F): 05/09/2017

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 8010
• Device Catalogue Number: CS 8010
• Device Lot Number: MDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2017
• Date Report to Manufacturer: 05/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• 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: Hospitalization