MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM; ROD, 6MM, STRAIGHT, LENGTH 45MM,

Model Number CS 3807-045

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2024

Event Type  Injury  

Event Description

A few weeks following the surgical procedure, it was discovered that a rod was fractured.A revision surgery was required to replace it.Cause of the fracture is unknown.

• Brand Name: UCENTUM
• Type of Device: ROD, 6MM, STRAIGHT, LENGTH 45MM,
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 18822786
• MDR Text Key: 336734520
• Report Number: 3005823819-2024-00003
• Device Sequence Number: 1
• Product Code: NKB
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS 3807-045
• Device Catalogue Number: CS 3807-045
• Device Lot Number: U038012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2024
• Device Age: 1 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 120 KG