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

Catalog Number 03.30.202

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 04/06/2018

Event Type  malfunction  

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 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
• Type of Device: PLATE FLUSH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7487004
• MDR Text Key: 107756034
• Report Number: 3005180920-2018-00302
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030833564
• UDI-Public: 07630030833564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Catalogue Number: 03.30.202
• Device Lot Number: 143313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other