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

Model Number	7680265
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were provided and the event was confirmed.The device has been returned and analysis is pending.The patient reported an impact which may be a contributing factor.Review of the device history records indicates all material types, treatments and dimensions were within specification.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; loss of purchase; sizing issues with components; anatomical or technical difficulties." "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.Note: additional surgery may be necessary to correct some of the adverse effects.".
Event or Problem Description
On (b)(6) 2016, a (b)(6)female underwent anterior cervical discectomy and implantation of a prosthetic device.Around 3 months post-operatively, it was reported the patient fell and the caudal portion of the device migrated anteriorly.A revision surgery was performed (b)(6) 2016.The device was explanted and the patient received an acdf.

• 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: 6121939
• Report Number: 2031966-2016-00082
• Device Sequence Number: 11045101
• Product Code: MJO
• UDI-Device Identifier: 00887517081124
• UDI-Public: 00887517081124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/22/2016

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: No Information
• Device Model Number: 7680265
• Device Lot Number: SV8405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR