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

Catalog Number	03.30.132
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 may 2019 lot 1720418: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-11-02.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.Clinical evaluation performed by (b)(4): the clinical analysis cannot help determining the cause for this blackout of one screw in alif application for l5s1 fusion.From the two radiographs supplied, we were unable to identify anything critical.
Event or Problem Description
The surgeon discovered that one of the screw backed out.The surgeon doesn't revise the screw but he is monitoring this patient to understand if the screw is continuing to back-out.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED
• Common Device Name: ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8599631
• Report Number: 3005180920-2019-00362
• Device Sequence Number: 2180273
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: 11/02/2022
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1720418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/10/2019
• 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