MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MYSPINE LP DRILL PILOT GUIDE L04

Catalog Number	7.0554
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2020: lot 02581s: (b)(4) item manufactured and released on 23-jan-2020.No anomalies found related to the problem.Patient match planing review each step of the process have been analyzed by my solution department.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.Planning: the surgeon modified and validated the planning (rev.1).Guide: the guide was designed according to the trajectory of the screws in the planning validated (rev.1).As usual, during the guide design we checked with the upper and the lower vertebra that there was no impingement.Conclusions our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
It was not possible to use myspine guide l4 because there was a problem related to its settng.The patient lamina of l4/l5 were too closer, so in order to set the myspine guide l4, the patient lamina l4 should have been recected.The surgery finished without using myspine guide.30 minutes delay and additional anesthesia has been used.

• Brand Name: MYSPINE MYSPINE LP DRILL PILOT GUIDE L04
• Common Device Name: DRILL PILOT GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9799371
• Report Number: 3005180920-2020-00131
• Device Sequence Number: 16304445
• Product Code: MNI
• UDI-Device Identifier: 07630040716864
• UDI-Public: 07630040716864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153273
• 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
• Report Date (Section B): 02/06/2020

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: 7.0554
• Device Lot Number: 02581S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: Required Intervention
• Patient Age: 69 YR