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

Model Number 7680465

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Two prostheses were implanted on (b)(6) 2014 at the c4-c5 and c5-c6 disc spaces.In (b)(6) 2014 (3 months post-op), radiographs indicated that the inferior plate of the c4-c5 prosthesis exhibited anterior migration.Revision surgery occurred on (b)(6) 2014 to remove the device from c5-c6 and perform an acdf procedure.

Manufacturer Narrative

Nuvasive reference (b)(4).The reported event was confirmed via radiographic.Two prostheses were implanted at the c4-c5 and c5-c6 spine levels.The inferior plate of the c4-c5 prosthesis exhibits anterior migration.The explanted device has not been returned.No root cause has been identified.The pcm prosthetic device has been evaluated for, and is approved for single-level spinal correction.The fact that two pcm devices were implanted at adjacent levels may have contributed to the reported event.Labeling review: "the pcm cervical disc is indicated for use in skeletally mature pts for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-c7 following single-level discectomy"."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.".

• Brand Name: PCM CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk boulevard; san diego, CA 92121 ; 8583205285
• MDR Report Key: 4012691
• MDR Text Key: 4689100
• Report Number: 2031966-2014-00045
• Device Sequence Number: 1
• Product Code: MJO
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2014

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
• Device Operator: Health Professional
• Device Model Number: 7680465
• Device Lot Number: SV8120
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Home
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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