MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X); SPINE CERVICAL SCREW

Model Number 03.70.020

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

About 4 months after the primary surgery, the patient came in for a post-op appointment and x-rays revealed that a screw had backed out at c6 and broke.It is unknown how this occurred and which of reported lots was involved.The surgeon plans to monitor the patient and not revise at this time.

Manufacturer Narrative

Batch review performed on 17 june 2022.Lot 2121007:(b)(4).Expiration date: 2026-04-26.No anomalies found related to the problem.(b)(4).Other device potentially involved (it is unknown which lot is the broken one): mecta c 03.70.020 variable self-drilling screw diam.4x18mm (2x) (k140361) lot.1620618: (b)(4).Expiration date: 2025-11-30.No anomalies found related to the problem.(b)(4).Clinical evaluation performed by medical affairs department about 4 months after cervical stabilization surgery, on postoperative examination, an x-ray image shows that one of the screws has partially backed out.From the one image provided, the screw itself is also broken.The back out is small and not clinically dangerous at the moment; in fact, the surgeon decided not to revise.The causes of the back out are currently unknown; in case of reintervention, it will be possible to analyze the explants and perhaps formulate a hypothesis.

• Brand Name: MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)
• Type of Device: SPINE CERVICAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14797028
• MDR Text Key: 300635754
• Report Number: 3005180920-2022-00482
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07630030840043
• UDI-Public: 07630030840043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.70.020
• Device Catalogue Number: 03.70.020
• Device Lot Number: 2121007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2021
• 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): Other
• Patient Sex: Male