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

Model Number	7680465
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiograph confirmed the event.The device has returned for evaluation; however, results are still pending.No further investigation can be completed at this time.No root cause has been determined.Patient's bone quality, activity level or compliance with post-operative care instructions are unknown.Review of the device history records notes no material non-conformances or manufacturing errors that may have caused or contributed to this mode of failure.Labeling review: "risks associated with implants in the spine, including the pcm cervical disc device, are: early or late loosening of the components; disassembly; bending or breakage of any or all of the components; implant migration; malpositioning of the implant." "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.".
Event or Problem Description
On (b)(6) 2016, a prosthesis device was implanted into a patient at level c5-6.Approximately 4 months following surgery, a radiographic image indicated the inferior endplate had migrated anteriorly.The device was removed (b)(6) 2016 and an anterior cervical fusion was performed.

• 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: 5961070
• Report Number: 2031966-2016-00070
• Device Sequence Number: 10782314
• Product Code: MJO
• UDI-Device Identifier: 00887517081186
• UDI-Public: 00887517081186
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2016

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: No Information
• Device Model Number: 7680465
• Device Lot Number: SV8089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1