MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X9 L5

Model Number	03.26.044
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 august 2020: lot 1822656: (b)(4) items manufactured and released on 30-sept-2019.Expiration date: 2024-09-14.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.Clinical evaluation performed by medical affairs director: few weeks after bi-level fusion with pedicle screws (different manufacturer) and interbody devices, one of the level shows an expelled cage and loose screws.This may be due to an unforeseen movement of the patient or a lack of compression, as well as to poor bone quality in the pedicles.There is no hint that the adverse event was caused by a defective device.
Event or Problem Description
Primary surgery was performed on (b)(6) 2020.Tlif surgery was performed with the mectalif oblique cage and competitor's pedicle screws at l3-l5.Pedicle screw 7mm was inserted into the l3-l5, and the mectalif oblique cage h10mm was inserted into the l3-l5, and the mectalif oblique cage h9mm was inserted into the l4-l5.2 weeks after the primary surgery, the surgeon discovered the back out of the mectalif oblique cage and the loosening of the pedicle screw at l4-l5 by ct scan.Revision surgery was performed on (b)(6) 2020 (1 month after primary surgery).The surgeon replaced with the one more bigger size with the all pedicle screws.The surgeon removed the mectalif oblique cage h9m from the patient vertebra, and inserted the mectalif oblique cage 12x28x12 l5°.The surgeon impacted the mectalif oblique cage with the hammer in order not to be back out again.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X9 L5
• Common Device Name: OBLIQUE INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10519959
• Report Number: 3005180920-2020-00590
• Device Sequence Number: 14216785
• Product Code: MAX
• UDI-Device Identifier: 07630030830631
• UDI-Public: 07630030830631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 09/14/2024
• Device Model Number: 03.26.044
• Device Catalogue Number: 03.26.044
• Device Lot Number: 1822656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/11/2020
• 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
• Patient Age: 73 YR