MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG H

Model Number	03.30.156
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020: lot 1922392: (b)(4) items manufactured and released on 8-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the primary spine surgery, during the final tightening of the screws, the surgeon was using the final tightener and one of the screws continued to spin inside the plate(the plate didn't have any damage and the lot is unavailable) after being screwed in all the way.The surgeon tried to remove the screw for 30 minutes and it would not come out.The surgeon left the screw in the plate since it was secure, and used the same final tightener to tighten the other screws (screwdriver used as in surgical technique recommendation).The surgery was completed successfully and a consignment set was utilized.There was no issue during cage insertion.The bone was prepared according to the surgical technique, there was no bone damage.No additional anesthesia was necessary.The is no information on which hole of the plate has the issue.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG H
• Common Device Name: SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10996071
• Report Number: 3005180920-2020-00897
• Device Sequence Number: 777834
• Product Code: OVD
• UDI-Device Identifier: 07630040727969
• UDI-Public: 07630040727969
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2024
• Device Model Number: 03.30.156
• Device Catalogue Number: 03.30.156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/12/2020
• 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: Required Intervention