MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X10 L5°

Catalog Number	03.26.045
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional comments provided by the surgeon: the primary surgery was the first experience of myspine surgery for the surgeon, so the surgeon was not familiar with the surgical procedure.The screw trajectory might have been different from the planning.The pedicle screw might have not been well fixed.The cage size might have been slightly larger.Batch review performed on 21 december 2018: lot 152173: (b)(4).Expiration date: 2021-05-19.No anomalies found related to the problem.(b)(4).The mysolution department review the patient match plan and commented as follows: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation performed by medical affairs director: migration of interbody oblique cage in a case of primary lumbar stabilization with cortical bone trajectory.The surgeon felt that the cortical screws may have loosened slightly even during primary surgery, and tried to compensate with the use of cross-connectors, but after few weeks the cage mobilized anyway.It is conceivable that the cause for mobilization was insufficient stability provided by the construct, but no defective device has been identified and reported.The migreted cage has been repositioned and left in situ.
Event or Problem Description
Tlif surgery performed at l4-l6 with myspine mc guide on (b)(6) 2018.At that time the surgeon felt the pedicle screws might be loosened during compression at l5-l6, so in order to strengthen the fixation, the surgeon used total 2 cross connectors.The patient alleged pain about 2 weeks later after the primary surgery.The surgeon discovered the mectalif oblique cage implanted at l5-l6 was migrated to posterior side in the x-ray.Revision surgery performed on (b)(6)(1 month and a half after primary surgery), at that time the surgeon replaced the pedicle screw with new one and impacted the same mectalif oblique cage into the intervertebral disc space again.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X10 L5°
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8188869
• Report Number: 3005180920-2018-01033
• Device Sequence Number: 16673758
• Product Code: MAX
• UDI-Device Identifier: 07630030830648
• UDI-Public: 07630030830648
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 03.26.045
• Device Lot Number: 152173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/21/2018
• 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: 65 YR