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	No Information (3190)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirmed the event.The caudal endplate of the device appears to be subluxated anteriorly approximately 3mm-4mm relative to the cranial endplate into the anterior margin of the c6 vertebral endplate.The explanted device did not return to nuvasive.No further investigation can be performed.Review of the device history records do not show any 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; loss of purchase; sizing issues with components; anatomical or technical difficulties.".
Event or Problem Description
Initial surgery was performed (b)(6) 2016, during which a prosthetic device was implanted at the c5-6 disc space.Approximately 5 weeks following surgery, it was noted the prosthesis had migrated anteriorly.The affected level was revised on (b)(6) 2016.Patient condition and status of health prior to event is unknown.Patient activity level, bone quality, and compliance with post-surgical instructions are unknown.

• 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: 5656018
• Report Number: 2031966-2016-00038
• Device Sequence Number: 21138
• Product Code: MJO
• UDI-Device Identifier: 00887517081162
• UDI-Public: 00887517081162
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/11/2016

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: 7680372
• Device Lot Number: SV8074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1