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

Model Number	03.70.020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3005180920-2022-00482
• Device Sequence Number: 12011869
• Product Code: KWQ
• UDI-Device Identifier: 07630030840043
• UDI-Public: 07630030840043
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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: 04/26/2026
• Device Model Number: 03.70.020
• Device Catalogue Number: 03.70.020
• Device Lot Number: 2121007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2021
• 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: Other
• Patient Sex: Male