MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ULRICH MEDICAL; PEDICLE PROBE WITH BALL HANDLE, THORACIC, LENGTH 230 MM

Catalog Number	UL 8527-23
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Intraoperative breakage of a pedicle probe.It was not possible to complete the planned procedure.

• Brand Name: ULRICH MEDICAL
• Common Device Name: PEDICLE PROBE WITH BALL HANDLE, THORACIC, LENGTH 230 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: 24687488
• Report Number: 9612420-2025-00105
• Device Sequence Number: 10004178
• Product Code: HXB
• UDI-Device Identifier: 04052536052936
• UDI-Public: 04052536052936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/25/2026

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 Catalogue Number: UL 8527-23
• Device Lot Number: A220632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female