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

Catalog Number 7.0554

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  Injury  

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 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
• Type of Device: DRILL PILOT GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9799371
• MDR Text Key: 188933600
• Report Number: 3005180920-2020-00131
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 07630040716864
• UDI-Public: 07630040716864
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7.0554
• Device Lot Number: 02581S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR