MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE-MC DRILL GUIDE L03; INSTRUMENT FOR SPINE SURGERY

Model Number	7.0723
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analyisi perfromed by 3d printed guide project manager: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We reprinted the guides and bone models and we checked the fitting and it conformed.We also spoke with the surgeon and he too confirmed that the fitting was ok and that he found it difficult because it was a complicated case due to the patient's morphology.
Event or Problem Description
During the primary spine surgery, the myspine guides did not fit properly on the vertebrae after dissection.The surgeon used a bridge guide at l4 was able to use the myspine guides but had to use fluoroscopy at l5.There was a 1 hour and 30 minute delay due to guides issue and additional anesthesia was administered.The surgery was completed successfully.Total surgery time: 3.5 to 4 hours.

• Brand Name: MYSPINE-MC DRILL GUIDE L03
• Common Device Name: INSTRUMENT FOR SPINE SURGERY
• 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: 17000836
• Report Number: 3005180920-2023-00389
• Device Sequence Number: 15115612
• Product Code: PQC
• UDI-Device Identifier: 07630040717519
• UDI-Public: 07630040717519
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7.0723
• Device Catalogue Number: 7.0723
• Device Lot Number: 09423S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Female