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

Model Number 7180033006

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2017

Event Type  malfunction  

Manufacturer Narrative

The surgeon reported a larger vbr should have been selected.Radiographs were not received.The implant was not returned for evaluation.Review of manufacturing records indicates no non-conformances with respect to material type, material treatments or dimensions.The patient's bone integrity and/or size selection may have contributed to the event.The reported event was not confirmed and no root cause can be determined at this time.Review of labeling notes: 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: "correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic and internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.".

Event Description

On (b)(6) 2017, an (b)(6) female patient with bone fragility underwent a vertebral body replacement (vbr) with posterior fixation at the adjacent levels.On february 26, 2017, the vbr components were reported to have separated.A revision surgery took place (b)(6) 2017.

• 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 ; 8589091980
• MDR Report Key: 6463478
• MDR Text Key: 72348000
• Report Number: 2031966-2017-00036
• 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: 04/06/2017

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: 7180033006
• Device Lot Number: DR6426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/06/2017
• 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: 82 YR