MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW LOCKING TOWER ENHANCED

Catalog Number	03.51.10.0183
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary spine surgery, the surgeon complained that the must locking tower assembly did not properly reduce rod or lock the screw from a polyaxial to monoaxial screw.This process of locking the screws, reducing the rod, and locking the set screw caused a considerable delay in surgery.The surgeon continued using the rod and alternating screws and the reduction instrument randomly many times until the surgery was complete.There was a 30-minute delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
On the 19 december 2019 we were informed that the devices involved are not available.
Event or Problem Description
On the 19 december 2019 we were informed that the devices involved are not available.

• Brand Name: PEDICLE SCREW LOCKING TOWER ENHANCED
• Common Device Name: LOCKING TOWER ENHANCED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9260077
• Report Number: 3005180920-2019-00916
• Device Sequence Number: 16796008
• Product Code: LXH
• UDI-Device Identifier: 07630971226425
• UDI-Public: 07630971226425
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/15/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.51.10.0183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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