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

Model Number	7680365
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Headache (1880); Failure of Implant (1924); Neck Pain (2433)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not provided for review.The device has not returned; therefore, no further investigation can be completed at this time.The patient reportedly was exercising immediately prior to the onset of pain.It is not clear if the patient had adhered to the post-operative care plan communicated by the surgeon.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 instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".
Event or Problem Description
On (b)(6) 2015, a (b)(6) year old male underwent anterior cervical discectomy with antroplasty.During a postoperative visit, the patient reported sudden onset of neck pain and headache.A revision surgery occurred on (b)(6) 2016 to remove the device.It was noted the caudal portion of the device had migrated anterior 7mm and the cranial portion was still in the original position.

• 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: 5530693
• Report Number: 2031966-2016-00022
• Device Sequence Number: 299697
• Product Code: MJO
• UDI-Device Identifier: 00887517081155
• UDI-Public: 00887517081155
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P100012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2016

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: 7680365
• Device Lot Number: SV8361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR