MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ULRICH MEDICAL; SCREW, CANNULATED, PRE-ANGLED MEDIAL, Ø 4.0 MM, LENGTH 36 MM

Catalog Number	CS 3902-40-36
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Postoperative screw breakage after approximately 10 months led to revision surgery.

• Brand Name: ULRICH MEDICAL
• Common Device Name: SCREW, CANNULATED, PRE-ANGLED MEDIAL, Ø 4.0 MM, LENGTH 36 MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 23787104
• Report Number: 9612420-2025-00104
• Device Sequence Number: 5520433
• Product Code: KWP
• UDI-Device Identifier: 04052536084524
• UDI-Public: 04052536084524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 161032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: Lay User/Patient
• Device Catalogue Number: CS 3902-40-36
• Device Lot Number: U035179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male