MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ULRICH MEDICAL; SCREW, Ø 3.5 MM, LENGTH 14 MM

Model Number	CS 3902-35-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"breakage of a pedicle-screw during surgery.This results in a delay in the operation time.According to reporting person: "we are very sorry to inform you that the item.Broke during the surgery and part of it has been left inside the patient."".
Event or Problem Description
"breakage of a pedicle-screw during surgery.This results in a delay in the operation time.According to reporting person: "we are very sorry to inform you that the item broke during the surgery and part of it has been left inside the patient."".

• Brand Name: ULRICH MEDICAL
• Common Device Name: SCREW, Ø 3.5 MM, LENGTH 14 MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-w[?]rttemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-w[?]rttemberg 89081 ; GM 89081
• MDR Report Key: 22018886
• Report Number: 9612420-2025-00103
• Device Sequence Number: 18494801
• Product Code: NKG
• UDI-Device Identifier: 04052536084197
• UDI-Public: 04052536084197
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: 888.450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: Health Professional
• Device Model Number: CS 3902-35-14
• Device Lot Number: U044976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male