MAUDE Adverse Event Report: NUVASIVE, INC. NVM5; STIMULATOR, NERVE

Model Number	2029950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Lateral lumbar interbody fusion (xlif) with dr.Nuvasive nvm5 xlif disposable kit, ref: 2029950, lot: 1802231, exp: 2023-01-22, had black ink like substance come off of dilator (looks like from the inside of the blue (largest) dilator).Contaminated items removed from surgical field.Dilators with packaging sent to risk management.

• Brand Name: NVM5
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 7560685
• Report Number: 7560685
• Device Sequence Number: 1529707
• Product Code: ETN
• UDI-Device Identifier: 00887517170606
• UDI-Public: (01)00887517170606
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018
• Report Date (Section F): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/22/2023
• Device Model Number: 2029950
• Device Catalogue Number: 2029950
• Device Lot Number: 1802231
• Other Device ID Number: 9402342 A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELDERLY FEMALE PATIENT UNDERGOING L2/3 & L3/4 XLIF
• Patient Age: 67 YR
• Patient Weight: 107
• Date Report Sent to FDA: 05/24/2018