MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI 9X22X12 L5

Catalog Number	03.27.115
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 december 2020: lot 1922752: (b)(4) items manufactured and released on 06-dec-2019.Expiration date: 2024-11-12.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.Note that two equal devices (same ref and lot) have been reported in this case.Visual inspection performed by r&d project manager: the cages ref 03.27.115, lot no.1922752 do not present any signs of damage or of deformation.The parts are according to the specifications.According to the description of the event, the root cause of the complaint (the backout of the implants) could be the physical altercation that the patient had with the nurse.
Event or Problem Description
The patient came in reporting pain and the cause of the pain is unknown.Post-op x-rays indicated that cages ejected into the canal after the primary surgery.The surgeon removed the cages 28 days after primary and did not put any implants in to replace them.The surgery was completed successfully.It should be noted that the patient got into a physical altercation in post-op care.This is most likely the reason why the cages ended up free floating.The agent thinks the surgeon may have put bone graft in place but is not 100% certain.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI 9X22X12 L5
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11037512
• Report Number: 3005180920-2020-00952
• Device Sequence Number: 13780051
• Product Code: MAX
• UDI-Device Identifier: 07630040719452
• UDI-Public: 07630040719452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181970
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 11/12/2024
• Device Catalogue Number: 03.27.115
• Device Lot Number: 1922752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/18/2020
• 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