MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE LP GUIDE L04; SURGICAL GUIDE FOR SPINE SURGERY

Catalog Number	7.0524
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018: lot 00607s: (b)(4) items manufactured and released on 22 march 2018.Expiration date: 2018-09-09 no anomalies found related to the problem.Investigation performed by mysolution department on 07 june 2018: we analyzed each step of the myspine process; no errors have been found.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.The surgeon complained about a interspinous ligament - guide interference; anyway, this is a check that we are not able to previously verify, since on the ct scan it is not possible to see the soft tissue (like the ligament).The only check we perform is the interference amongst the guide, the upper vertebra and the lower vertebra.
Event or Problem Description
During a case that was supposed to be an l4-l5 fusion, the l4 myspine guide bridge seated too low.The surgeon had to take down the interspinous ligament between l3 and l4 in order for the guide to seat properly.Additionally the l5 guide was very large and the surgeon did not want to have to expose so much.Intraoperatively the surgeon made the decision to perform a decompression.The surgeon mentioned that his decision to perform a decompression was not a result of the myspine guides but based on the patient's anatomy.

• Brand Name: MYSPINE LP GUIDE L04
• 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: 7578031
• Report Number: 3005180920-2018-00402
• Device Sequence Number: 209782
• Product Code: MNI
• UDI-Device Identifier: 07630030878060
• UDI-Public: 07630030878060
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/07/2018

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: 09/09/2018
• Device Catalogue Number: 7.0524
• Device Lot Number: 00607S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/07/2018
• 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: 65 YR