MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE® VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number	8550002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation, nor were radiographs provided to confirm the reported event.Labeling review: "as with any major surgical procedures, there are risks involved in orthopedic surgery." "potential risks identified with the use of this system, which may require additional surgery, include: implants cutting through soft osteoporotic, osteolienic or cancellous bone." no product returned.
Event or Problem Description
Information received states laminar band sawed through bone tissue.No other event information has been provided or radiographs that confirm the reported event.No revision procedure was reported.
Additional Manufacturer Narrative
Received information stating lamina breakage was unrelated to product malfunction.Posterior fixation was applied and laminectomy was completed.No revision procedure was required.

• Brand Name: NUVASIVE® VERSATIE SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7007365
• Report Number: 2031966-2017-00163
• Device Sequence Number: 16368750
• Product Code: OWI
• UDI-Device Identifier: 00887517721525
• UDI-Public: 00887517721525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: Physician
• Device Model Number: 8550002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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: Other
• Patient Age: 64 YR