MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) INTERBODY FUSION DEVICE 12X28X11 L10; SPINE INTERBODY FUSION DEVICE

Model Number	03.26.051
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 march 2020: lot 1820570: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-14.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.Additional device involved: batch reviews performed on 16 march 2020: pedicle screw 03.50.029 pedicle screw 7x35 (k121115) lot 1821270: (b)(4) items manufactured and released on 21-jan-2019.Expiration date: 2024-01-03.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.Pedicle screw 03.50.029 pedicle screw 7x35 (k121115) lot 1821500: (b)(4) items manufactured and released on 08-feb-2019.Expiration date: 2024-01-15.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.
Event or Problem Description
Plif surgery was performed at l3-l4, and tlif surgery was performed at l4-l5.The surgeon inserted the 6mm pedicle screws at l3-l4, and the 7mm pedicle screws at l5.The surgeon inserted the 2 posterior cages to l3/l4, and the oblique cage to l4/l5.Patient bone quality was normal.After the surgery, the patient alleged a strong pain because of loosening of the pedicle screws at l5 and the back out of the cage at l4/l5.The surgeon removed the rod and the both side of pedicle screws at l5.The surgeon removed the oblique cage and inserted the new oblique cage at l4-l5.The surgeon also inserted the 8mm x 40mm pedicle screw at l5.The surgeon performed the compression and add the cross link.Revision performed successfully 19 days after primary.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) INTERBODY FUSION DEVICE 12X28X11 L10
• Common Device Name: SPINE INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9909845
• Report Number: 3005180920-2020-00211
• Device Sequence Number: 19651360
• Product Code: MAX
• UDI-Device Identifier: 07630030830709
• UDI-Public: 07630030830709
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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: 02/14/2024
• Device Model Number: 03.26.051
• Device Catalogue Number: 03.26.051
• Device Lot Number: 1820570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/01/2020
• 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: 70 YR