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

Catalog Number	03.27.148
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 august 2021.Lot 1922678: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-10-26.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
4 months after the primary the patient came in reporting pain and the cause of the pain was unknown.The surgeon took x-rays and it was observed the loosening of the pedicle screw, not medacta, and the back out of the cage.The patient's bone was osteoporotic.The surgeon revised the mectalif posterior tipeek 9x25x13 l10° and the surgery was completed successfully.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12486766
• Report Number: 3005180920-2021-00747
• Device Sequence Number: 19733658
• Product Code: MAX
• UDI-Device Identifier: 07630040719780
• UDI-Public: 07630040719780
• 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: 2021
• Device Explanted Year: 2021
• 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): 09/17/2021

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: 10/26/2024
• Device Catalogue Number: 03.27.148
• Device Lot Number: 1922678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/17/2021
• 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