MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF STAND ALONE CERVICAL; ACDF MECTA-C SA - PLATE TRIO LOCK H5

Model Number	03.18.305
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 may 2025: lot 2326808: (b)(4) items manufactured and released on 06-dec-2023.Expiration date: 2028-11-13.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.Additional device involved: batch review performed on 27 may 2025: acdf 03.18.602 mecta-c sa drill screw lock ø3.8x14 (1x) (k192906) lot 2226827: (b)(4) items manufactured and released on 29-mar-2023.Expiration date: 2028-03-05.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.Visual inspection performed by r&d project manager: a mecta-c sa implant (cage ref.03.18.101, lot no.2326796; plate ref.(b)(4) lot no.2326808) was removed from the patient after a metal burr was observed protruding from one of the threaded holes during screw insertion (ref.(b)(4), lot no.2226827).According to the event description, the awling and tapping steps were performed prior to screw insertion.Upon receipt, the components were analyzed: the screw exhibited no damage, and its outer diameter was found to be within specifications.It is therefore considered likely that the metal burr did not originate from the screw, but from the plate, which may have been damaged during the tapping process.The potential root cause of the complaint may be cross-threading between the tap and the plate.Clinical evaluation performed by medical affairs director a mecta-c sa implant was explanted intra-operatively after a metal burr was observed protruding from one of the threaded holes of the plate during screw insertion.According to the event report, the awling and tapping steps were performed prior to screw placement.The analysis conducted by the r&d department on the retrieved implant indicated most likely that the metal burr originated from the plate itself.The available x-ray image was taken postoperatively, therefore it does not provide insight into the intraoperative phase (e.G., the initial position of the construct, the direction of tapping or screw insertion).However, the image does not show any evidence of residual metal fragments left in the patient, therefore no secondary issues for the patient are expected as a result of this event.No patient harm was reported, with the only noted impact being a surgical delay of approximately 30 minutes.Although the specific circumstances cannot be confirmed, the potential root cause of the event is cross-threading between the tap and the plate during the tapping phase.No systemic deficiency can be identified and the device history record review does not indicate any potential manufacturing related cause.
Event or Problem Description
After placement of the cage, the surgeon prepared the screw holes using awl and tap.During screw insertion, part of the thread (burrs) was seen coming out of the plate.The surgeon decided to remove the implant and replace it with cage mecta-c.Operating level c4-c6, no anatomical abnormalities noted.Approximately 30 minutes delay during a total surgery time of a couple of hours in order to remove the implant and retrieve the other cage with its dedicated instrumentation.Surgery completed successfully.

• Brand Name: ACDF STAND ALONE CERVICAL
• Common Device Name: ACDF MECTA-C SA - PLATE TRIO LOCK H5
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22201145
• Report Number: 3005180920-2025-00550
• Device Sequence Number: 7644471
• Product Code: OVE
• UDI-Device Identifier: 07630040725934
• UDI-Public: 07630040725934
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.18.305
• Device Lot Number: 2326808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White