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

Catalog Number 03.26.045

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 11/27/2018

Event Type  Injury  

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 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°
• Type of Device: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8188869
• MDR Text Key: 131139418
• Report Number: 3005180920-2018-01033
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030830648
• UDI-Public: 07630030830648
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 03.26.045
• Device Lot Number: 152173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR