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

Model Number	7680372
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.A review of photographic images provided confirm the reported event.No product will be returned for evaluation as it has been kept by the facility.Labeling review: post-operative: ".Patients should be instructed in postoperative procedures and the importance of adherence to these procedures.Postoperative care includes, neck support, activity modification for a period of time after surgery and formal rehabilitation." ".The patient should be made aware of the limitations of the implant and potential adverse effects 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." no product returned.
Event or Problem Description
On (b)(6) 2018 patient underwent a procedure where a porous coated motion (pcm) device was used.A revision procedure was performed on (b)(6) 2018 due to a migration of the device.No patient injury has been reported.

• Brand Name: PCM CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7614527
• Report Number: 2031966-2018-00109
• Device Sequence Number: 1555594
• Product Code: MJO
• UDI-Device Identifier: 00887517081162
• UDI-Public: 00887517081162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: Physician
• Device Model Number: 7680372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/19/2018
• Patient Sequence Number: 1