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

Model Number 7680365

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Headache (1880); Failure of Implant (1924); Neck Pain (2433)

Event Date 03/01/2016

Event Type  malfunction  

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 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
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: kim mccaleb ; 7475 lusk blvd; san diego, CA 92121 ; 8589091980
• MDR Report Key: 5530693
• MDR Text Key: 41307562
• Report Number: 2031966-2016-00022
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00887517081155
• UDI-Public: 00887517081155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7680365
• Device Lot Number: SV8361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR