MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR; SPINE LAG PLATE

Model Number	03.30.300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 aug 2024: lot 2325474: 34 items manufactured and released on 20-dec-2023.Expiration date: 2028-11-20.No anomalies found related to the problem.To date, 04 items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by r&d project manager: parts need to be inspected for a correct analysis to identify a root cause for this complaint.
Event or Problem Description
The anti-backout screw chipped off in the implant and the surgeon was not able to insert it.He left the broken threaded portion of the screw in the implant and then used a non-medacta anterior plate as a means to prevent screw back out.The surgeon confirmed that the screw sheared off as he was attempting to tighten it using the standard torque driver.He did not use a mallet or any other instrument.There was a 5-minute delay and the surgery was completed successfully.
Additional Manufacturer Narrative
On 04-nov-2024 we were informed that the implant is not available for analysis.Correction d9 section.Root cause: due to the lack of information it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.Section d1 brand name was updated as per gudid.Reference put in the correct field d4 (model number).

• Brand Name: MECTALIF ANTERIOR
• Common Device Name: SPINE LAG PLATE
• 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: 20167667
• Report Number: 3005180920-2024-00728
• Device Sequence Number: 8249744
• Product Code: OVD
• UDI-Device Identifier: 07630345732286
• UDI-Public: 07630345732286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 03.30.300
• Device Catalogue Number: 03.30.300
• Device Lot Number: 2325474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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: Female