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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation, radiographs were received december 16, 2017 and confirm the reported event.No revision procedure is planned at this time.It is unknown if patient complied with post-operative restrictions.No root cause can be determined.Labeling review: ".Contraindications include but are not limited to: patients who are unwilling to restrict activities or follow medical advice." ".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.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." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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." ".Proceed to turn the handle clockwise to drive the set screw.As the set screw flanges begin to deploy, a tactile torque spike will be felt.Continue driving down the set screw until the handle "breaks away" and an audible "click" sound is heard.Now the set screw flanges are fully deployed and the bolt is locked in the bolt pocket (fig.9).Repeat technique for remaining bolts.To remove implant inserter, rotate thumbwheel counterclockwise until inserter is returned to an unlocked position.Carefully remove the implant inserter from the implant and operative site." ".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" ".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 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." device left in-situ.

Event Description

On (b)(6) 2017 a patient underwent an anterior lumbar interbody fusion procedure with posterior fixation at l5-s1 levels without any reported issues.On (b)(6) 2017 a follow up radiograph showed a screw backing out.No patient injury reported and no revision procedure planned at this time.

• 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: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 7149900
• MDR Text Key: 95909373
• Report Number: 2031966-2017-00187
• Device Sequence Number: 1
• Product Code: OVD
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• 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: 58 YR