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

Model Number	03.30.112
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
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 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.
Additional 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
• 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: 15994327
• Report Number: 3005180920-2022-00929
• Device Sequence Number: 17573891
• Product Code: OVD
• UDI-Device Identifier: 07630030875342
• UDI-Public: 07630030875342
• 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: 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
• 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: 04/08/2019
• 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 Age: 41 YR
• Patient Sex: Female