MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM

Catalog Number	03.30.201
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 23 march 2018; infection occurred 3 months after intervertebral body fusion surgery.Infection is a known possible adverse event following every surgery, including spine surgeries.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch review performed on 29 march 2018; lot 140603: (b)(4) items manufactured and released on 14 may 2014 expiration date:2019-03-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectalif anterior stand-alone tipeek cage 27x35x12 lordosis 15° reference 03.31.027 (k160605) lot 143344:50 items manufactured and released on 05 sept 20014.Expiration date: 2019-07-31 no anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any similar reported event.Mectalif anterior stand-alone screw diam.5x25 (double packaging) reference 03.30.121 (k124034) lot 148227: 120 items manufactured and released on 05 sept 2016.Expiration date: 2021-08-24 no anomalies found related to the problem.To date, 16 items of the same lot have been already sold without a similar reported event (2 items of this lot involved in this complaint) mectalif anterior stand-alone screw diam.5x30 (double packaging) reference 03.30.122 (k124034) lot 140626 164 items manufactured and released on 07 august 2014.Expiration date: 2019-06-30 no anomalies found related to the problem.To date, 137 items of the same lot have been already sold without any similar reported event (2 pieces of this lot involved in this complaint).
Event or Problem Description
About 3 months after primary the surgeon revised the patient for an infection.The surgery was completed successfully.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM
• Common Device Name: ANTERIOR STAND-ALONE PLATE FLUSH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7380661
• Report Number: 3005180920-2018-00192
• Device Sequence Number: 113657
• Product Code: OVD
• UDI-Device Identifier: 07630030833557
• UDI-Public: 07630030833557
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K124034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: 03/31/2019
• Device Catalogue Number: 03.30.201
• Device Lot Number: 140603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• 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