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

Model Number	7680472
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Failure of Implant (1924); Weakness (2145)
Date of Event	01/06/2016
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.Review of the device history records for this lot does not note any material non-conformances or manufacturing errors that may have caused or contributed to this event.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.".
Event or Problem Description
On (b)(6) 2015, a (b)(6) male underwent anterior cervical discectomy with arthroplasty at c5-6.During a post-operative visit, the patient reported significant weakness in the right arm.A revision surgery occurred on (b)(6) 2016 to remove the device.It was noted the prothesis had extruded anteriorly.

• 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: 5449278
• Report Number: 2031966-2016-00006
• Device Sequence Number: 561990
• Product Code: MJO
• UDI-Device Identifier: 00887517081193
• UDI-Public: 00887517081193
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/18/2016

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: 7680472
• Device Lot Number: SV8191
• 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: 02/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR