MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE; MYSPINE LP DRILL PILOT GUIDE L02

Model Number	7.0552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 dec 2025.Lot 19105s: (b)(4) items manufactured and released on 15-nov-2025.Expiration date: 2026-mar-24.No anomalies found related to the problem.Patient match planning review spine.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We have reproduced the guide of l02 with its bone model, in order to check the fitting again.We can confirm the stability and conformity of the guide.Investigation performed by r&d project manager.The l02 guide and l02 bone models have been reprinted to evaluate the fitting.The guide perfectly docked on the bone model, and the tubes&size39; trajectories are aligned with the planning validated by the surgeon.Root cause:while a definitive root cause could not be established, the investigation did not identify any deviations or anomalies in the device used, the planning protocol, or the manufacturing of the patient-specific guides.The incident is potentially attributable to intraoperative variables, such as suboptimal guide placement or bone preparation, or anatomical variations of the bone structure that may have arisen between the preoperative ct acquisition and the surgical procedure.
Event or Problem Description
During primary spine surgery, the surgeon securely docked the l2 spine guide, but when implanting the pedicle screw, it breached the pedicle.It is unknown why this occurred.The surgeon removed the screw and adjusted the trajectory for implantation to complete the case.There was a 10-minute delay, and the case was completed successfully.

• Brand Name: MYSPINE
• Common Device Name: MYSPINE LP DRILL PILOT GUIDE L02
• 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: 23858466
• Report Number: 3005180920-2025-01274
• Device Sequence Number: 10374649
• Product Code: MNI
• UDI-Device Identifier: 07630040716826
• UDI-Public: 07630040716826
• Combination Product (Y/N): N
• PMA/510(K) Number: K153273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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 Expiration Date: 03/24/2026
• Device Model Number: 7.0552
• Device Lot Number: 19105S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2025
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White