MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MC SYSTEM; MYSPINE SYSTEM

Model Number	7.0704
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 january 2021: lot 03982s: (b)(4) items manufactured and released on 22-dec-2020.Expiration date: 2021-06-07.No anomalies found related to the problem.Myspine planning review: images qc: the images we received were subjected to quality control, the result of which was positive after the confirmation about patient surname from the branch; 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 modified the planning, after that, the branch informed us in order to make additional modification for the levels l04, l05, s01 and s02.Finally, the surgeon validate the case; guide: the guide was designed according to the trajectory of the screws in the planning validated.We wrote to the branch to inform the surgeon about some osteotomies and some indication because these vertebrae has a particular morphology.Moreover, we wrote also for the increased tubes length.Conclusions: our analysis of the myspine process of this case found no deviations from the standard procedures.
Event or Problem Description
Spinal fixtaion was performed at l4-s2 with myspine guides.The surgeon was not able to set the myspine guide l4 and l5 on the patient bone because the bone model was completely different from the patient bone.The surgeon inserted the pedicle screw at l4-l5 without using the myspine guide.The surgeon was difficult to set the myspine guide s1 and s2 on the patient bone because the sleeve was designed into the hole.It was hard to confirm if the guide was correctly set on during the surgery.Due to this event the surgery was prolonged about 1 hour.Total surgery time was about 5 hours.The surgeon expressed an opinion that he felt the myspine accuracy became lower than in the past.L5 osteotomy was performed according to planning but the patient bone shape and the bone model shape were significantly different.The surgeon felt that the bone model were recected too much.

• Brand Name: MYSPINE MC SYSTEM
• Common Device Name: MYSPINE SYSTEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11341872
• Report Number: 3005180920-2021-00126
• Device Sequence Number: 4759799
• Product Code: PQC
• UDI-Device Identifier: 07630040717298
• UDI-Public: 07630040717298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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 Expiration Date: 06/07/2021
• Device Model Number: 7.0704
• Device Catalogue Number: 7.0704
• Device Lot Number: 03982S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• 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: 76 YR