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

Model Number	CS 3801-01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/19/2018
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 4) filed 8/7/2018.
Event or Problem Description
Surgeon used standard set screws with prefixation screws instead of the prefixation set screws that fit with them.Post op x-rays revealed rod was migrating.Revision was done (b)(6) 2018 repositioning the rod and replacing standard set screws with correct prefixation set screws.Report 4/4.

• Brand Name: UCENTUM
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8745548
• Report Number: 9612420-2019-00027
• Device Sequence Number: 16476334
• Product Code: NKB
• UDI-Device Identifier: 04052536078646
• UDI-Public: 4052536078646
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123717
• 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): 06/25/2019
• Report Date (Section F): 07/13/2018

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 3801-01
• Device Catalogue Number: CS 3801-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• 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: 78 YR