MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE FIXED SELF-DRILLING SCREW DIAM. 4X16MM (1X)

Model Number	03.70.144
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 07.Aug.2020: lot 1520489: (b)(4) items manufactured and released on 3-mar-2016.Expiration date: 2021-02-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by clinical affairs director: few weeks after cervical stabilization, one of the screws holding the plate has backed off and needs revision.These screws are equipped with a system that, when correctly operated, prevents them from withdrawing from the plate.We could not determine from the radiographs if all steps were carried out correctly and of course the devices are not available for technical inspection at the time being.Also, the instruments were not returned for inspection to check if a malfunction may have occurred, so we cannot determine a potential cause for this adverse event.Additional item involved in the event, batch review performed by medacta regulatory affairs department on 07.Aug.2020: cervical plate 03.70.394 fixed self-tapping screw diam.4.5x16mm (1x) (k140361) lot.1520541.Lot 1520541: (b)(4) items manufactured and released on 9-jun-2016.Expiration date: 2021-05-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
Revision surgery performed after 3 months from the primary surgery due to one inferior screw within the 3 level plate construct is sitting proud of the plate (unscrewed) and requires removal/revision.No issues were noted during the surgery and the screws were torqued off according to the surgical technique.Revision surgery was successful, the surgeon revised the screw.We don't know the correct lot number of the revised screw, it will be provided after receiving.
Additional Manufacturer Narrative
Visual inspection: based on the available information, it was supposed that the screw was properly seated in the plate before performing the final tightening, and that it did not protrude out from the plate.By looking the x-ray it is well visible that the screw migrated from the plate, while the small locking screw still seems in the proper position, that is fully seated in the bone screw.During the visual inspecion on retrived implants was observed and confirmed that the small looking screw was fully seated and fixed in the bone screw, generating the expansion of the head.However, it is not clear why the bone screw protruded out from the plate.It might be happen that during the final tightening of small locking screw the bone screw was partially seated in the plate, and not fully introduced as explained in the surgical technique.In that position the risk of screw migration increase notably.

• Brand Name: CERVICAL PLATE FIXED SELF-DRILLING SCREW DIAM. 4X16MM (1X)
• Common Device Name: FIXED SELF-DRILLING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10482360
• Report Number: 3005180920-2020-00532
• Device Sequence Number: 4092676
• Product Code: KWQ
• UDI-Device Identifier: 07630030840838
• UDI-Public: 07630030840838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/20/2020

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: 02/08/2021
• Device Model Number: 03.70.144
• Device Catalogue Number: 03.70.144
• Device Lot Number: 1520489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR