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

Model Number 03.30.133

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 305582085
• Report Number: 3005180920-2022-00930
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male