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

Model Number 03.30.146

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23 nov 2022.Lot 2023945: (b)(4) items manufactured and released on 12-feb-2021.Expiration date: 2026-01-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Other component potentially involved: mectalif anterior 03.30.146 mectalif anterior stand-alone screw diam.5x30 long head (k183426) lot.2124222: (b)(4) items manufactured and released on 06-sep-2021.Expiration date: 2026-08-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: at 1 year after lumbo-sacral stabilization, fusion did not take place and one or possibly two sacral screws of the standalone cage broke.This patient had lateral pars defects and spondylolisthesis, situations that may subject the implant to increased stress; in these conditions, if fusion does not take place, the implant is subject to prolonged intense stress and therefore fracture may occur after the standard fusion time (between 6 and 12 months, normally).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.

Event Description

The surgeon noted after surgery that the s1 screw/s had broken.He noted there was not a complete fusion across the cage and eventually decided to further stabilize the patient with posterior fixation 6 months 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.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
• 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: 16002393
• MDR Text Key: 305681871
• Report Number: 3005180920-2022-00932
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183426
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.30.146
• Device Catalogue Number: 03.30.146
• Device Lot Number: 2023945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2021
• 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: 37 YR
• Patient Sex: Male