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

Model Number	CS 3810-01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Crosslink snapped during final tightening.Report 2 of 3.

• Brand Name: UCENTUM
• Common Device Name: CROSSLINK
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8950393
• Report Number: 3005823819-2019-00008
• Device Sequence Number: 2129294
• Product Code: NKB
• UDI-Device Identifier: 04052536080854
• UDI-Public: 4052536080854
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2019
• Report Date (Section F): 08/30/2019

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: No Information
• Device Model Number: CS 3810-01
• Device Catalogue Number: CS 3810-01
• Device Lot Number: U005883
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2019
• 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