MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X9 L5°

Catalog Number	03.27.007
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Joint Disorder (2373)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2017.Lot 1520377: (b)(4) items manufactured and released on 13 december 2016.Expiration date: 2021-11-23.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.On 20 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: a plif lumbar cage backed out from l4-l5 few weeks after surgery.Supplemental posterior stabilization was also applied at the time of primary surgery.Three weeks radiographic images show the loosening of a screw.The reason of the cage backing out are not known.A reduced stabilization caused by the screw loosening in the early postoperative period may have contributed.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.
Event or Problem Description
The primary surgery on l4-l5 was finished successfully as usual.The surgeon used a medacta spinal cage with non-medacta pedicle screws.After the surgery follow-up, the surgeon confirmed the migration of one cage and the loosening of the screw on one side.Patient had neurologic symptoms.The revision surgery was completed successfully on (b)(6) 2017.The surgeon felt that the cage had a root cause, even if loosening of one screw was also detected.Even though mectalif tipeek cages have a titanium coating, the surgeon has an impression that mectalif tipeek cages tend to migrate because the surface roughness and the height of pyramids would be lower than other cages on the market.

• Brand Name: MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X9 L5°
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6965045
• Report Number: 3005180920-2017-00598
• Device Sequence Number: 1142565
• Product Code: MAX
• UDI-Device Identifier: 07630030831492
• UDI-Public: 07630030831492
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 11/23/2021
• Device Catalogue Number: 03.27.007
• Device Lot Number: 1520377
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/20/2017
• 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: 69 YR