MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180027006

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

Radiographs were not received.The implants remain in-situ.Revision surgery has not occurred.The reported event was not confirmed and no root cause can be determined at this time, although the significant comorbidities or possible impact/trauma may have contributed to the event.No further investigation can be completed at this time.No patient injury has been reported.Potential adverse events and complications: "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss fixation, nonunion or delayed union, fracture of the vertebra, implant subsidence".Warnings, cautions and precautions: "internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant".

Event Description

On (b)(6) 2017, a (b)(6) year old female with significant comorbidities underwent a corpectomy at t12 receiving a vertebral body replacement (vbr) and posterior fusion at t9-11/l1-3.On (b)(6) 2017, it was noted that the l1 superior endcap was damaged.The vbr migrated to the left and rod deflection was detected.

• Brand Name: NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: kim mccaleb ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 6386521
• MDR Text Key: 69326135
• Report Number: 2031966-2017-00021
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7180027006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR