MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF MECTA-C SA - PLATE FLUSH LAG H6; SPINE PLATE FLUSH LAG

Model Number	03.18.216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The acdf anti-back out broke during surgery while the surgeon tried to tighten it a little bit more with forceps.The surgery was completed leaving the part of the broken screw stuck in the plate so without locking cup on the construct.
Additional Manufacturer Narrative
Batch review performed on 08 august 2022: lot 1922140: (b)(4).Expiration date: 2025-01-07.No anomalies found related to the problem.(b)(4).The application shaft act as a torque limiter and should break off as soon as the final tightening torque is reached.The surgeon has reacted correct, the best would have been to either try to remove the remaining piece with a forceps and to use a new anti back-out plate or to replace the implant.The surgeon should definitely careful monitor the patient and keep an eye on screw migration, screw back-out can happen but don't have to.However, the complication can be sever if it happens.It seems that he accepted the potential risk since he was not willing to replace the device/locking screw.
Additional Manufacturer Narrative
On 7 november 2022, the branch confirmed that the device of this complaint is not available.

• Brand Name: ACDF MECTA-C SA - PLATE FLUSH LAG H6
• Common Device Name: SPINE PLATE FLUSH LAG
• 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: 15370482
• Report Number: 3005180920-2022-00669
• Device Sequence Number: 6077903
• Product Code: OVE
• UDI-Device Identifier: 07630040725866
• UDI-Public: 07630040725866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/28/2022

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 Expiration Date: 01/07/2025
• Device Model Number: 03.18.216
• Device Catalogue Number: 03.18.216
• Device Lot Number: 1922140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Race: White