MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5; SPINE INTERBODY FUSION DEVICE

Model Number	03.27.006
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2020: lot 1822231: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-10-23.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 on the (b)(6) 2020 by medacta medical affairs director: shortly (few weeks) after posterior lumbar stabilization with two plif cages the surgeon discovers that both cages have moved, along with one pedicle screw, and therefore replaces them with an oblique cage.There is no reason to suspect that a defective device originated this problem which is more likely due to technical reasons or perhaps patient behaviour.Additional device involved: batch review performed on 09 april 2020: mectalif posterior (ti peek) 03.27.006 posterior interbody fusion device peek/ti 11x22x7 l5° (k133192) lot 141273a: (b)(4) items manufactured and released on 07-oct-2019.Expiration date: 2024-09-17.No anomalies found related to the problem since 2016.To date, (b)(4) item of the same lot has been already sold without any similar reported event.
Event or Problem Description
Plif surgery was performed at l4-l5 on (b)(6) 2020.The surgeon discovered at x-rays that the one cage was backed out and another was rotated between the vertebral body space.Revision surgery was performed on march 30 (26 days after primary surgery).The surgeon removed both cages and inserted the mectalif oblique cage h9 x l5°.The surgeon discovered the loosening of the pedicle screw at l5, so the surgeon replaced the 7mm pedicle screw with the 7.5mm pedicle screw.Pedicle screws were not medacta's.
Additional Manufacturer Narrative
On may 06th 2020 we have received the items involved in the complaint.Visual inspection performed by r&d project manager: the cage 03.27.006 lot 141273 doesn't present evident cracks or damage neither on the body nor on the pyramids.The cage 03.27.006 lot 1822231 presents some scratches and coating delamination on the posterior side of the implant and dirt in the thread is present but no damages on the pyramids are visible.The overall dimensions of the implants (length, height and width) are conformed and the height of the pyramids on both sides is in tolerance, therefore, conformed.Considering the information provided and what is stated above the roote cause of the mobilization could be the non-correct compression of the implants due to the screw loosening.The scratches and the damages visible on the posterior side of one cage are probably due to the removal of the implant during the revision surgery.

• Brand Name: MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5
• Common Device Name: SPINE INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10008595
• Report Number: 3005180920-2020-00259
• Device Sequence Number: 14177335
• 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,Followup
• Report Date (Section B): 06/05/2020

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: 10/23/2024
• Device Model Number: 03.27.006
• Device Catalogue Number: 03.27.006
• Device Lot Number: 1822231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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: 85 YR