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

Catalog Number	03.30.132
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2018: lot 1621564: 100 items manufactured and released on 27 july 2013.Expiration date: 2022-06-21.No anomalies found related to the issue.To date, 77 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on (b)(6) 2018 3 months after primary alif at l5-s1 the patient was complaining about pain.One screw was found broken but no implant removal was planned.Radiographic image quality doesn't allow a proper clinical evaluation.
Event or Problem Description
The patient had a primary alif at l5-s1.The patient came in complaining of pain.The surgeon determined that the screw broke.There is currently no plan to revise the patient.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED (DOUBLE PACKAGING)
• Common Device Name: ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544747
• Report Number: 3005180920-2018-00378
• Device Sequence Number: 1862309
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: 06/21/2022
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1621564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• 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