MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180041A

Device Problems Collapse (1099); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Radiographs provided confirmed the alleged event.Inspection of the returned device found physical damage to the auto locking feature as well as gearing consistent with an incomplete inserter engagement.A lack of final lock screw engagement and an intact spot weld indicate incomplete final lock screw engagement.Even though root cause cannot be confirmed based on the investigation performed, the result may be related to an unintended use error.No instrumentation was returned for evaluation.No additional investigation can be completed at this time.Reported incident is related to reported event 200049508/ mw# 2031966-2020-00117 with out a reported issue.Labeling review: ".Warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Preoperative warnings 3.Care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.5.Inspect all components for damage before use.6.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

On (b)(6) 2020 patient underwent a revision procedure.As per reporter, a ct scan taken on (b)(6) 2020, showed the implant had collapsed and patient underwent a second revision procedure on (b)(6) 2020.

Event Description

See h10 for updated information.

Manufacturer Narrative

The implant and instrumentation were returned to nuvasive and the complaint confirmed.Product evaluation and testing determined the root cause to be the result of incomplete inserter attachment and subsequent damage to auto-lock mechanism in combination with a lack final lock screw activation.No additional investigation required.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).Loss of fixation.Nonunion or delayed union.Fracture of the vertebra.Implant subsidence." ".Warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.In order to ensure proper inserter/implant engagement, the inserter¿s colored distal tip must face up toward the like-colored spinning sleeve of the implant.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pre-operative warnings 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

• Brand Name: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10423729
• MDR Text Key: 205670300
• Report Number: 2031966-2020-00163
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00887517365835
• UDI-Public: 887517365835
• Combination Product (y/n): N
• PMA/PMN Number: K090176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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
• Device Operator: Health Professional
• Device Model Number: 7180041A
• Device Lot Number: NN1843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6).
• Patient Outcome(s): Hospitalization; Required Intervention