MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MYSPINE MC DRILL BASED GUIDE L04; DRILL GUIDE FOR SPINE SURGERY

Catalog Number	7.0724
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient match planning review as per your request, we analyzed each step of the myspine process.Images qc: the images we received were subjected to quality control, the result of which was positive.Reconstruction: the reconstruction is precise and correct, all areas were clearly identifiable.The reconstructed profiles follow accurately the contour of the vertebrae: planning: the surgeon validated our first planning proposal.The guides were designed according to the trajectory of the screws in the planning validated by the surgeon.Conclusions our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Additional device involved: myspine 7.0725 myspine mc drill based guide l05 (k173472) lot.02494s.All the items involved are related to lot number 02494s batch review performed on 28 january 2019: lot 02494s: (b)(4) guides manufactured and released on 02-jan-2020.No anomalies found related to the problem.
Event or Problem Description
The surgeon was not able to set the myspine mc guide correctly at l4- l5.The surgeon finished the surgery without using the myspine mc guide.Due to this event the surgery was prolonged about 1 hour.Total surgery time about 200 mins.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the myspine bone models (ref.7.0704-7.0705) and the myspine guides (ref.7.0724-7.0725) of l4 and l5 respectively have been inspected for a deeper investigation of the complaint.The fitting between the bone models and the guides of l4 and l5 results are fully conforming: the guide can be docked and removed from the bone model without any issue (see image 1 and 2 attached).Furthermore, from the visual inspection, it can be noticed that there is no impingement between the guide and the upper facet joints.Due to the fact, the facets of the upper vertebrae (l3 for l4 guide and l4 for l5 guide) not needed to be resected.

• Brand Name: MYSPINE MYSPINE MC DRILL BASED GUIDE L04
• Common Device Name: DRILL GUIDE FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9710937
• Report Number: 3005180920-2020-00059
• Device Sequence Number: 3650376
• Product Code: PQC
• UDI-Device Identifier: 07630040717533
• UDI-Public: 07630040717533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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 Catalogue Number: 7.0724
• Device Lot Number: 02494S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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