MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE DRILL GUIDE L01; SURGICAL GUIDE FOR SPINE SURGERY

Catalog Number	7.0121
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 29 may 2018 after a call between surgeon and medacta: it is possible that the event is due to a malpositioning of the guides in docking phase in addition to a particular deformed anatomy of the patient and the learing phase of the surgeon.Batch review performed on 05 june 2018; lot 00615s: (b)(4) items manufactured and released on 29 march 2018.Expiration date: 2018-09-12; no anomalies found related to the problem.
Event or Problem Description
During post-op control the surgeon noticed that some screws were out (l1, l2 and l3, in the disc or medially) and therefore with a different trajectory respect to myspine planning.The patient has no symptons and no revision surgery is planned at the moment.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2018: a lumbar arthrodesis operation was conducted with the help of patient-specific guides.At the end of the operation, the screw position proved unsatisfactory at radiological examination, but no clinical consequence is to be expected, according to the surgeon's evaluation.There is no clinical cause to this event and it could either be a technical error during surgery or a defect in the guides.We have no elements to make a decision in either sense.

• Brand Name: MYSPINE DRILL GUIDE L01
• Common Device Name: SURGICAL GUIDE FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7582504
• Report Number: 3005180920-2018-00410
• Device Sequence Number: 2365095
• Product Code: MNI
• UDI-Device Identifier: 07630030856679
• UDI-Public: 07630030856679
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K132788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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 Expiration Date: 09/12/2018
• Device Catalogue Number: 7.0121
• Device Lot Number: 00615S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: Required Intervention
• Patient Age: 15 YR