MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MYSPINE MC DRILL BASED GUIDE L05; PATIENT MATCHED DRILLING GUIDE FOR SPINE SURGERY

Catalog Number	7.0725
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-may-2020: lot 02969s: (b)(4) items manufactured and released on 17-apr-2020.No anomalies found related to the problem.Myspine planning review performed by pmt department.Our analysis of the myspine process shows that no deviations from the standard procedures were found; each step was performed correctly.
Event or Problem Description
During the primary spine surgery, while the surgeon was implanting the left screw at l5, a lateral breach of the left l5 vertebrae occurred.There was a 15-minute delay and the surgeon free-handed the screw.The surgery was completed successfully.The surgeon followed the procedure and did not experience any issues with any of the other screws in this case or his previous case.There was no breach until the surgeon fully implanted the screw.No fitting issue has been reported between bone model/patient's bone and guides.

• Brand Name: MYSPINE MYSPINE MC DRILL BASED GUIDE L05
• Common Device Name: PATIENT MATCHED DRILLING GUIDE FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10095418
• Report Number: 3005180920-2020-00297
• Device Sequence Number: 3406223
• Product Code: PQC
• UDI-Device Identifier: 07630040717557
• UDI-Public: 07630040717557
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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 Catalogue Number: 7.0725
• Device Lot Number: 02969S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR