MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE; MYSPINE-MC DRILL GUIDE

Model Number	7.0725
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Tlif surgery was successfully performed at l5-s1 with myspine mc guide.A few days later, ct scan revealed that upper-level l5 screw had perforated the cranial intervertebral disc.The surgeon pointed out that the lower part of the guide sleeve had been shortened and there was an excessive space between the guide and the bone model.
Additional Manufacturer Narrative
Batch review performed on 14 march 2023: lot 15994s: (b)(4) items manufactured and released on 17-jan-2025.Expiration date: 2025-07-06.No anomalies found related to the problem.Analysis performed by mysolution department: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Investigation performed by r&d project manager.The guides have been produced according to myspine process and no deviations from the procedure have been detected.Disc perforation has been discussed with the sale rep.The superimposition of the post-op image with the pre-op planning showed that the post-op trajectory mostly corresponded with the pre-op one, only a slight cranial movement was detected.Moreover, the pre-op screw was close to the cranial endplate and a small variation of the trajectory could have reached the superior endplate.Being the myspine process respected and the guide-bone fitting result good, it can be concluded that the perforation is not related to the guide.Clinical evaluation performed by clinical affairs department a proximal l5 endplate violation was detected during a follow-up ct after l5-s1 fusion surgery using the myspine mc guide.Only one ct slice is available and it is affected by artifacts from the metallic screw; so the visualization of the construct is very limited.However, it does appears to confirm that the screw is violating the superior endplate.It is unclear whether this has any consequences for the residual disc, as the intervertebral space appears very thin, indicating that the disc is almost completely degenerated.In general, endplate perforation in spinal fusion surgery may lead to secondary issues like micro-instability or pain.However, in this case, the violation appears to be very limited, and given the partial visualization of the construct, it is not possible to determine with certainty whether secondary issues will affect the patient.It is likely that this type of issue will not cause any consequences, but it is the surgeon's responsibility to evaluate this based on a complete clinical and imaging assessment.

• Brand Name: MYSPINE
• Common Device Name: MYSPINE-MC DRILL GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21737328
• Report Number: 3005180920-2025-00252
• Device Sequence Number: 4022193
• Product Code: PQC
• UDI-Device Identifier: 07630040717557
• UDI-Public: 07630040717557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173472
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 07/06/2025
• Device Model Number: 7.0725
• Device Lot Number: 15994S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian