MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.14 MM

Catalog Number	03.30.202
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 may 2018.Lot 143313: (b)(4) items manufactured and released on 25 june 2015, expiration date: 2020-06-07.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.Instruments involved: mectalif reference (b)(4) alif straight inserter mectalif reference (b)(4) alif inserter inner shaft preliminary investigation performed by r&d spine director on 10 april 2018.The instrument is designed that the pins of the instrument go through the plate into the cage, for this reason with the available information it is not possible understand what could have happened during surgery.
Event or Problem Description
After implantation of a mectalif ti peek anterior cage with flush plate, the surgeon was attempting to change the rotational position of the cage within the disc space to match the anatomy.The flush plate became disassociated from the cage.A second cage and flush plate was opened to complete the surgery.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.14 MM
• Common Device Name: PLATE FLUSH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7487004
• Report Number: 3005180920-2018-00302
• Device Sequence Number: 18880592
• Product Code: OVD
• UDI-Device Identifier: 07630030833564
• UDI-Public: 07630030833564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 06/07/2020
• Device Catalogue Number: 03.30.202
• Device Lot Number: 143313
• 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: 04/06/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: Other