MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR; SPINE INSTRUMENT

Catalog Number	03.22.10.7041
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 february 2019: lot 1857766: (b)(4) items manufactured and released on 21-may-2019.No anomalies found related to the problem.To date no any similar event reported.Other device involved: myspine 7.0724 myspine mc drill based guide l04 (k173472) batch review performed on 07 february 2020: lot 02633s: (b)(4) items manufactured and released on 21-jan-2020.No anomalies found related to the problem.
Event or Problem Description
During the primary spine surgery, while the surgeon was performing l4/5 posterior lumber fusion, and when placing both the l4/5 guides, the surgeon had planned to place 45mm screws in l4 and 40 mm screws in l5 due to the trajectory from the drills he was only able to place 35 mm screws.In addition, when the surgeon went to check ap fluoroscopy placement of the l4 right sided pedicle he noticed a medial break of the pedicle.The surgeon had drilled and placed pedicle markers, when this was found.After performing his decompression, he went back and revised the l4 screw trajectory with a free hand approach.The total delay with the guides and replacement of the l4 screw was 20 minutes.The surgery was completed successfully.

• Brand Name: MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR
• Common Device Name: SPINE INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9755013
• Report Number: 3005180920-2020-00091
• Device Sequence Number: 16698234
• Product Code: LXH
• UDI-Device Identifier: 07630971235847
• UDI-Public: 07630971235847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.22.10.7041
• Device Lot Number: 1857766
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• 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; Required Intervention
• Patient Age: 52 YR