MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM

Model Number CS 3802-065-050

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2022

Event Type  Injury  

Event Description

Revision spondylodesis.

• Brand Name: UCENTUM
• Type of Device: SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 15954890
• MDR Text Key: 305240411
• Report Number: 3005823819-2022-00025
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536078844
• UDI-Public: 04052536078844
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CS 3802-065-050
• Device Catalogue Number: CS 3802-065-050
• Device Lot Number: U034762
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2022
• Device Age: 9 MO
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention