MAUDE Adverse Event Report: Medacta International SA Spine instrument; MySpine Cervical Probe Ø3.2 -35mm Mech stop short

Model Number	03.75.10.0348
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Neuropathy (1983); Peripheral Nervous Injury (4414)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• Brand Name: Spine instrument
• Common Device Name: MySpine Cervical Probe Ø3.2 -35mm Mech stop short
• Manufacturer (Section D): Medacta International SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 50006552
• Report Number: 3005180920-2026-00785
• Device Sequence Number: 13376295
• Product Code: LXH
• UDI-Device Identifier: 07630542716263
• UDI-Public: 07630542716263
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.75.10.0348
• Device Lot Number: 2475311
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 56 YR
• Patient Sex: Male
• Patient Race: Asian