MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE MODULUS-C INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	67940036
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.A review of radiographs provided confirm the alleged event.No revision procedure is planned at this time.Reportedly the patient is asymptomatic.Labeling review: ".Potential adverse events and complications: 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." ".Warnings, cautions and precautions:if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ¿¿patient education:the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components." ¿¿post-operative warnings:damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration.".
Event or Problem Description
A patient underwent a spinal procedure on c5-7 levels on (b)(6) 2019.A post-op radiograph taken on an unknown date revealed that the cage has migrated.There are no plans for a revision procedure per the surgeon.

• Brand Name: NUVASIVE MODULUS-C INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10423751
• Report Number: 2031966-2020-00164
• Device Sequence Number: 2961239
• Product Code: ODP
• UDI-Device Identifier: 00887517959416
• UDI-Public: 887517959416
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 67940036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR