MAUDE Adverse Event Report: NUVASIVE PCM CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	9500717
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	06/11/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ nor is there an allegation of product malfunction.No x-ray films were provided to confirm the alleged event.Warnings ".Correct selection of the appropriate implant size and correct placement of the device are essential to ensure optimal performance and function of the device." precautions ".Before selection of the implant, it is also important to note: the presence of anatomical abnormalities and/or deformities may reduce the possibility of the surgeon to ensure proper placement of the implant.In some instances, there may be interferences that prevent implantation.In these instances, it may be necessary to perform a fusion procedure.The target disc level should be confirmed radiographically to ensure proper placement of the implant and during the whole procedure (e.G., for sizing and safe placement of the implant)." potential adverse effects on health ".There is also the risk that this surgical procedure will not be effective, and may not relieve or may cause worsening of preoperative symptoms.".
Event or Problem Description
Received a voluntary report that stated, on (b)(6) 2014, patient underwent a cervical procedure.Post-operative patient suffered a car accident.As per reporter neurosurgeon believes pcm implanted may be too large based on mri.At this time patient will not undergo a revision procedure.

• Brand Name: PCM CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8689804
• Report Number: 2031966-2019-00206
• Device Sequence Number: 2359349
• Product Code: MJO
• UDI-Device Identifier: 00887517601148
• UDI-Public: 887517601148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9500717
• 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: 05/20/2019
• Initial Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization