MAUDE Adverse Event Report: NUVASIVE NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8452300
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation as it remains in-situ.No radiographs or images nor bone quality test results were provided to confirm the alleged event.At this time alleged event could not be confirmed.Insufficient information provided to determine the root cause.
Event or Problem Description
It was reported patient suffered a car accident and it was alleged nuvasive product has malfunctioned.A revision procedure will be conducted but is not planned at this time.
Additional Manufacturer Narrative
Additional information was received by patient's mother.
Event or Problem Description
Received new information indicating patient underwent a revision procedure on 09/04/2018.It is unknown if a nuvasive product was used at the time of the revision procedure.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8384724
• Report Number: 2031966-2019-00165
• Device Sequence Number: 16651603
• Product Code: NKB
• UDI-Device Identifier: 00887517219565
• UDI-Public: 887517219565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8452300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: Hospitalization