MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L5°; LUMBAR SPINE CAGE

Model Number	03.27.045
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-sep-2021: lot 1921806: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Osteolysis was found around the posterior interbody fusion device, 3 months post the first revision surgery.The patient was not revised yet.One single plif cage was implanted.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2021: few months after multilevel lumbar stabilization surgery, a suspected infection occurs and some implants are withdrawn.Osteolysis has been observed around one of the posterior cages used.This same observation has been reported by this same hospital previously; though it was never reported by any other hospital worldwide.A peculiarity of this case is the use of a single plif cage associated with the pedicle screw/rod system, but we cannot establish a relationship between this factor and the observed osteolysis.It's also possible that osteolysis and infection-mimicking symptoms are related to each other, but again this cannot be established with the information at hand.In addition the event description has been updated as per new info received on 21st and 22th october 2021.
Event or Problem Description
After a few weeks from the primary surgery, a pedicle screw loosening and a cage migration in l2/3 have been found.One single plif cage was implanted.Osteolysis was found around the posterior interbody fusion device.There was a suspicion of infection but it was not confirmed.On (b)(6) 2021 there was an extended fusion from l2 to s2ai, including cement augmentation in l2, the cage was replaced with a plif cage used in l2/3.On (b)(6) , 2021 there was another revision surgery where the cage in l2/3 was removed and was replaced with an xlif cage.
Additional Manufacturer Narrative
On 04-nov-2021 we have received the following information: the lot of the first cage was confirmed.The revision of sep 30th was confirmed to be due to cage migration and osteolysis.

• Brand Name: MECTALIF POSTERIOR POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L5°
• Common Device Name: LUMBAR SPINE CAGE
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 12519092
• Report Number: 3005180920-2021-00770
• Device Sequence Number: 19979529
• Product Code: MAX
• UDI-Device Identifier: 07630030831874
• UDI-Public: 07630030831874
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/29/2021

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: 10/07/2025
• Device Model Number: 03.27.045
• Device Catalogue Number: 03.27.045
• Device Lot Number: 1921806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male