MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MYSPINE MC DRILL-BASED GUIDE L04; PATIENT SPECIFIC SPINE GUIDE

Catalog Number	7.0724
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The drill guides didn't fit correctly on the l4/l5 patient vertebras.The guides were used during a non medacta products revision surgery, after competitor pedicle screw removal and bone vertebra docks for guides preparation.There was a 30-minute delay on a 4-hours surgery and the surgery was completed successfully.A competitor navigation system was used to complete the surgery and the delay was due to the navigation system set up.
Additional Manufacturer Narrative
Myspine process review.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 case in order to check the fitting again and the result was ok; the guides are completely stable with an optimal pad positioning.

• Brand Name: MYSPINE MYSPINE MC DRILL-BASED GUIDE L04
• Common Device Name: PATIENT SPECIFIC SPINE 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: 17911814
• Report Number: 3005180920-2023-00789
• Device Sequence Number: 15116829
• Product Code: PQC
• UDI-Device Identifier: 07630040717533
• UDI-Public: 07630040717533
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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 Expiration Date: 02/07/2024
• Device Catalogue Number: 7.0724
• Device Lot Number: 10822S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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