MAUDE Adverse Event Report: NANOVIS FORTICORE; FORTICORE PLIF INTERBODY SPACER

Model Number	11403-2810
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of manufacturing history shows product was released without anomaly.A review of complaint history shows no other complaints for this part or lot number.Waiting on the returned device to complete the investigation.A follow up report will be sent once the investigation is completed.Nanovis is continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.
Event or Problem Description
It was reported a patient underwent an initial spinal fusion procedure on (b)(6) 2019 utilizing a forticore plif spacer.Subsequently the patient underwent a revision procedure on (b)(6) 2019 due to migration.Current information is insufficient to permit a conclusion.Upon examination of the returned device a follow up report will be sent to the fda.
Additional Manufacturer Narrative
It should be noted the surgeon communicated to the sales associate that a larger size could have been used in the initial procedure (10mm x 28mm x 10mm 6 degree).It was confirmed a larger size was used in the revision procedure (12mm x 32mm x 11mm 6 degree).
Event or Problem Description
It was reported a patient underwent an initial spinal fusion procedure on (b)(6) 2019 utilizing a forticore plif spacer.Subsequently, the patient underwent a revision procedure on (b)(6) 2019 due to migration.This follow up report is to provide an update on the mfr report # 3009446038-2019-00002.The explanted product was discarded at the user facility and will not be returned for evaluation.Since the explanted product could not be evaluated a conclusive root cause for the event could not be determined.

• Brand Name: FORTICORE
• Common Device Name: FORTICORE PLIF INTERBODY SPACER
• Manufacturer (Section D): NANOVIS; 5865 e. state road 14; columbia city IN 46725
• MDR Report Key: 8434533
• Report Number: 3009446038-2019-00002
• Device Sequence Number: 1785863
• Product Code: MAX
• UDI-Device Identifier: 00814216021137
• UDI-Public: 00814216021137
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 09/09/2021
• Device Model Number: 11403-2810
• Device Catalogue Number: 11403-2810
• Device Lot Number: SM4156
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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: 48 YR