MAUDE Adverse Event Report: NUVASIVE, INC. ALIF INTERFIXATED SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 6955202

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.A review of the x-ray pictures provided confirm the alleged event.No revision procedure is planned at this time.Labeling: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." warnings, cautions and precautions ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs." patient education: ".The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." product remains in-situ.

Event Description

On (b)(6) 2017 patient underwent a procedure using the base interfixated titanium system.On (b)(6) 2018 during the six month follow up a screw fracture was noted.Patient is asymptomatic.

• Brand Name: ALIF INTERFIXATED SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7512484
• MDR Text Key: 108370491
• Report Number: 2031966-2018-00056
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517701749
• UDI-Public: 00887517701749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151214
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6955202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• 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