MAUDE Adverse Event Report: NUVASIVE NUVASIVE® MODULUS XLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1225260P2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it was left in-situ.No radiographs or images were provided to confirm the alleged event.No revision procedure has been planned at this time.Reportedly, the product may have been compromised during the procedure.Labeling review: "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)."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." post-operative warnings: ''damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as other complications." no product returned, as it is in-situ.
Event or Problem Description
A patient underwent an unknown procedure where a modulus cage was placed.On an unknown date, postoperative radiographs noted that the caged had migrated anteriorly.A revision procedure is being planned but has not been confirmed.No patient injury has been reported.
Additional Manufacturer Narrative
Patient underwent a revision procedure on (b)(6) 2019, where construct was removed with no issues.No patient injury reported.

• Brand Name: NUVASIVE® MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8705949
• Report Number: 2031966-2019-00208
• Device Sequence Number: 1992895
• Product Code: MAX
• UDI-Device Identifier: 00887517726964
• UDI-Public: 887517726964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 1225260P2
• Device Lot Number: ML1747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR