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

Model Number	67940003P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received.A review of manufacturing records was unable to be performed as the part and lot information of the device involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur."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.Malalignment of anatomical structures (i.E.Loss of normal spinal contours or change in height)." "warnings, cautions and precautions.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." ¿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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial one-level anterior cervical discectomy and fusion.Subsequently, a slight migration of the interbody cage and anterior plate from the anterior cortex was identified approximately one (1) month later.At approximately four (4) months post-op, further loosening of the plate as well as interbody subsidence was identified.No revision procedure has been reported to date.No additional patient consequences were reported.Report 2 of 2.
Event or Problem Description
See updated information listed in section h10.
Additional Manufacturer Narrative
New information provided in sections: b4, d4, g6, h2, h6, h10.

• Brand Name: NUVASIVE MODULUS-C INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13198294
• Report Number: 2031966-2022-00008
• Device Sequence Number: 4404194
• Product Code: ODP
• UDI-Device Identifier: 00887517959027
• UDI-Public: 887517959027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K172676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 67940003P2
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose