MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK 12X28X12 L10°

Catalog Number	03.20.052
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 16 june 2017 the medical affairs performed a clinical evaluation and commented as follows: a tlif lumbar cage backed out from l3-l4 few months after surgery.Supplemental posterior stabilization was also applied at the time of primary surgery.The reasons for the cage backing out are not known.Cage backing out from intervertebral space is a possible adverse event following interbody stabilization, described in literature.It can be caused by many factors, including insufficient thickness of the chosen cage, suboptimal insertion, and others.There is no ground to suspect a defective device.Batch review performed on 26 june 2017.Lot 133141: (b)(4) items manufactured and released on 24 september 2013.Expiration date: 2018-08-31.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.On 28 june 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: from the pictures enclosed in the complaint it is not possible to notice any deformation of the cage.Also the connection with the related instrument seems to be good.Based on the pictures there are no signs of mechanical neither functional failures.Not available.
Event or Problem Description
The patient came in complaining of left leg pain.A ct-myelogram showed the cage at l3-4 backed out.The surgeon planned to revise the patient at l3-4.If the cage had been loose, it would have been replaced with a larger one which would be implanted deeper (followed by compression on the l3-4 screws).If the cage had already begun to fuse, the protruding part would have been removed with the high-speed drill.At revision surgery, the surgeon removed the cage and closed the patient up.The surgery was completed successfully.In the future, the surgeon plans to implant another cage.X-rays are available, explants are not available.

• Brand Name: MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK 12X28X12 L10°
• Common Device Name: OBLIQUE INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6672560
• Report Number: 3005180920-2017-00344
• Device Sequence Number: 11255838
• Product Code: MAX
• UDI-Device Identifier: 07630030827747
• UDI-Public: 07630030827747
• Combination Product (Y/N): N
• PMA/510(K) Number: K131671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: 08/31/2018
• Device Catalogue Number: 03.20.052
• Device Lot Number: 133141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/28/2017
• 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: 54 YR