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

Model Number 03.30.112

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  Injury  

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 after the primary surgery.This patient had bilateral pars defect already at the day of the primary surgery with even a grade 1 of spondylolisthesis.

Manufacturer Narrative

Batch review performed on 23 nov 2022.Lot 1920274: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 2024-mar-23.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, and according to the report, this is what happened in this case.Posterior stabilization was deemed appropriate, also because the patient had developed evident spondylolisthesis.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: the instability caused by the pars defect did highly likely contribute to the fracture of the screws.Its recommended in the literature to back up these type of cases with posterior instrumentation.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 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: 15994327
• MDR Text Key: 305581406
• Report Number: 3005180920-2022-00929
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030875342
• UDI-Public: 07630030875342
• 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: 03/23/2024
• Device Model Number: 03.30.112
• Device Catalogue Number: 03.30.112
• Device Lot Number: 1920274
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2019
• 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 Age: 41 YR
• Patient Sex: Female