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

Model Number	7680359
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic images were received that confirmed the inferior plate migrated anteriorly.Evaluation of the explanted device as well as the device history record found no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.No patient injury reported.Labeling review: ".Pre-operative warnings patient selection is extremely important.Proper patient selection, including the adherence to the device's indications and contraindications, assessment of co-morbidities and medication use, consideration of the patient's occupation and activity level, mental health, and evaluation of all preoperative imaging studies, is critical to assuring optimum performance of the device.The patient should be mentally prepared and able to comprehend the importance of precautionary measures and to adhere to them." ".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 risks 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.The patient must be made aware that implant components may bend, break or loosen.Even though restrictions in activity are followed.The patient should be provided a copy of the pcm cervical disc patient information brochure.".
Event or Problem Description
On (b)(6) 2017 a patient underwent a porous coated motion implant placement procedure at c5-c6 levels with no reported issues.Post-operatively the patient suffered a fall during which the inferior plate migrated anteriorly.On (b)(6) 2017 a revision anterior cervical discectomy fusion procedure took place where the porous coated motion implant was replaced with another manufacturer's device.No patient injury reported.

• 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: 6940718
• Report Number: 2031966-2017-00134
• Device Sequence Number: 898269
• Product Code: MJO
• UDI-Device Identifier: 00887517601155
• UDI-Public: 00887517601155
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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: Physician
• Device Model Number: 7680359
• Device Lot Number: SV8271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR