MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MC VERTEBRA L04; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	7.0704
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot 00683s: (b)(4) items manufactured and released 11 may 2018.Expiration date: 2018-10-17 no anomalies found related to the issue.Other devices involved all of the same lot: reference 7.0705 (k173472) myspine mc vertebra l05; reference 7.0724 (k173472) myspine mc drill based guide l04; reference 7.0425 (k173472) myspine mc drill based guide l05.Clinical evaluation performed by medical affairs (b)(4) on 06 july 2018: l4-l5 cbt stabilization was performed using patient specific guides.The final position of the screws is not satisfactory, and different from planning.With the elements at hand, no further conclusion can be drawn.We are unable to identify a clinical cause for the event.Investigation performed by patient match department on 06 june 2018; our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.On 06 july 2018 they performed a further investigation and as a result they reported: the final trajectories of the screws implanted don't reflect the planned one.The planning was modified and validated by the surgeon as said in the previous analysis.The entry points are conform to the protocol and are positioned in a flat zone.
Event or Problem Description
The surgery was performed on (b)(6) with myspine mc guide.When the surgeon checked the ct image on (b)(6), he noticed that the pedicle screws were inserted in a different place in comparison with the planning.One of the pedicle screw protrudes laterally and the other one medially.

• Brand Name: MYSPINE MC VERTEBRA L04
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7666246
• Report Number: 3005180920-2018-00486
• Device Sequence Number: 1409852
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: 10/17/2018
• Device Catalogue Number: 7.0704
• Device Lot Number: 00683S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/06/2018
• 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: 70 YR