MAUDE Adverse Event Report: ULRICH GMBH & CO. KG FLAMENCO; 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	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
Screws and locking screws were getting threads damaged on final tightening.
Event or Problem Description
Report 1/7.
Additional Manufacturer Narrative
Follow up is being submitted based on retrospective review conducted 6/21/2019.Original mdr was submitted referencing "multiple lot numbers".Additional mdrs (2 through 7 of 7) were submitted 6/24/2019.This follow up adds a lot number to the original 1 of 7 mdrs.

• Brand Name: FLAMENCO
• Common Device Name: SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6614235
• Report Number: 9612420-2017-00016
• Device Sequence Number: 16296935
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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: NBM
• 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
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement 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