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

Model Number	2080252P2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product was repositioned and remains in-situ.No root cause can be determined at this time.Labeling review: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in spinal/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), loss of fixation, pain, discomfort or abnormal sensations due to the presence of the device." patient education ".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." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically post operatively.".
Event or Problem Description
On (b)(6) 2020, patient underwent a posterior lumbar interbody fusion procedure.On (b)(6) 2020, the patient was experiencing radiculopathy pain and additional xrays identified the left sided cage at the l5 to s1 levels had migrated back placing pressure on existing nerve roots.Patient underwent a revision procedure on (b)(6) 2020, were the cages were repositioned more medial and deeper.Grafting material was also placed in the posterolateral gutters.As per reporter the patient is doing well clinically with the radiculopathy settling.

• Brand Name: NUVASIVE MODULUS TLIF INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10287453
• Report Number: 2031966-2020-00147
• Device Sequence Number: 11031445
• Product Code: MAX
• UDI-Device Identifier: 00887517878939
• UDI-Public: 887517878939
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2080252P2
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 95