MAUDE Adverse Event Report: NEUROPRO SPINAL JAXX NEUROPRO SPINAL JAXX; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	100001-627
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon performed a surgery on (b)(6) 2022 in which he implanted a spinal jaxx implant, everything went fine.The patient did great for a few weeks after the surgery, and then developed severe leg pain.Surgeon obtained imaging studies that showed the implant had backed out into the canal.On (b)(6) 2022, surgeon performed a follow up surgery which went well, after which the patient felt complete relief.Nothing was wrong with the implant and surgeon attributed the backing out to surgeon error during the first surgery.The implant was removed during the second surgery and a new spinal jaxx implant was inserted deeper into the interbody space.Everything has seemed fine since then.

• Brand Name: NEUROPRO SPINAL JAXX
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NEUROPRO SPINAL JAXX; 6337 falling brook dr; burke VA 22015
• Manufacturer (Section G): NEUROPRO SPINAL JAXX; 6337 falling brook dr; burke VA 22015
• Manufacturer Contact: john green ; 6337 falling brook dr; burke, VA 22015 ; 5713347424
• MDR Report Key: 15940090
• Report Number: 3013378904-2022-00001
• Device Sequence Number: 6200720
• Product Code: MAX
• UDI-Device Identifier: 00818956021006
• UDI-Public: (01)00818956021006(10)191224I(17)240506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: 05/06/2024
• Device Model Number: 100001-627
• Device Catalogue Number: 100001-627
• Device Lot Number: 191224I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White