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

Model Number	03.27.006
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2020: lot 1820575: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Two devices of this lot were reported in this case.Visual inspection performed by medacta spine r&d project manager: the cages 03.27.006 lot 1820575 don't present any cracks or damage neither on the body nor on the pyramids.The thread of the posterior m4 thread of both implants is conformed: it is possible to mount / unmount the m4 gauge.Furthermore, the parts are checked randomly during the production and, after the coating, at 100% with an m4 go-nogo gauge.The route cause can be considered the incorrect mounting of the related inserter on the implant or the usage of a not conformed instrument.Furthermore, the overall dimensions of the implants (length, height and width) are conformed and the height of the pyramids on both sides is are in tolerance, therefore, conformed.Considering what is stated above the route cause of the mobilization could be the non-correct compression of the implants during the surgery.
Event or Problem Description
The surgeon inserted the trial cage to check the size of the cage, inserted the 2 cages into the patient disc space t11/t12, and performed the compression.After that the surgeon discovered the back out of the cage during the post operative final check.Revision surgery performed the same day of primary surgery and the surgeon tried to insert the 2 cages again, but it was not possible.Finally 2 cages were replaced with competitors devices.Competitor's pedicle screws and rods were used.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE
• Common Device Name: SPINE INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9909847
• Report Number: 3005180920-2020-00202
• Device Sequence Number: 19651361
• Product Code: MAX
• UDI-Device Identifier: 07630030831485
• UDI-Public: 07630030831485
• 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: 12/06/2023
• Device Model Number: 03.27.006
• Device Catalogue Number: 03.27.006
• Device Lot Number: 1820575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• 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