MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED

Model Number	03.30.133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 december 2022.Lot 1821427: (b)(4) items manufactured and released on 28-sep-2018.Expiration date: 2023-sep-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: 3 years after single level lumbo-sacral stabilization surgery a screw of the standalone cage is found broken.This can happen if the fusion process did not complete after more than 12 months.Posterior stabilization was deemed appropriate.Long term fracture of the screws in case of delayed fusion is a possible adverse event, listed in the safety documents of the product.Preliminary investigation performed by r&s spine director: delayed union is highly likely which result in a fatigue failure of the screw.Additional item involved in the event, batch review performed on 15 december 2022.Mectalif anterior 03.30.133 stand-alone screw diam.5x35 enhanced (double packaging) (k160605) lot.1821409.Lot 1821409: (b)(4) items manufactured and released on 30-aug-2018.Expiration date: 2023-aug-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The surgeon noted after surgery that the s1 screw had broken.The surgeon there was not a complete fusion across the cage and eventually decided to further stabilize the patient with posterior fixation, about 3 years and 5 months after the primary surgery.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED
• Common Device Name: ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15994328
• Report Number: 3005180920-2022-00930
• Device Sequence Number: 5724478
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2022

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: 09/17/2023
• Device Model Number: 03.30.133
• Device Catalogue Number: 03.30.133
• Device Lot Number: 1821427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male