MAUDE Adverse Event Report: NUVASIVE, INC. AP EXPANDABLE XLIF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 1672392

Device Problem Device Issue (2379)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor the radiographs were received for review.No information regarding the initial or removal surgery was provided.Root cause has not been determined and no conclusion can be drawn.The patient reportedly requested the explanted device be given to them.The implant is not currently available for evaluation.Review of labeling notes: "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, neurological, vascular or visceral injury, metal sensitivity or allergic reaction to a foreign body, infection, decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma, bursitis, dural leak, paralysis and death." device not received.

Event Description

On (b)(6) 2016 it was reported that a surgeon removed an implant from a patient.No reason for the removal was provided.No other information related to the event was provided.No patient injury was reported.

• Brand Name: AP EXPANDABLE XLIF SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 6137223
• MDR Text Key: 61204718
• Report Number: 2031966-2016-00085
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517454072
• UDI-Public: 00887517454072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1672392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• 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