MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE S01 DRILL BASED GUIDE

Catalog Number	7.0726
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04-nov-2019: lot 02007s: (b)(4) items manufactured and released on 17-sep-2019.No anomalies found related to the problem.Mysolution analysis: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.The guide size and the position of the tubes depend on the planned trajectory.
Event or Problem Description
During the primary spine surgery, while the surgeon was drilling the s1 guide holes, the surgeon observed that the s01 guide was too large for the incision made.The surgeon had to make his incision larger in order to use the s01 guide.There was a 35-minute delay in the case and no additional anaesthesia was used.The surgery was completed successfully.Case code: (b)(4).

• Brand Name: MYSPINE S01 DRILL BASED GUIDE
• Common Device Name: DRILL BASED GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9346918
• Report Number: 3005180920-2019-00975
• Device Sequence Number: 2901976
• Product Code: PQC
• UDI-Device Identifier: 07630040717571
• UDI-Public: 07630040717571
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7.0726
• Device Lot Number: 02007S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/20/2019
• 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: 62 YR