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

Model Number 7680372

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 c5-c6 and c6-c7 disc spaces.In (b)(6) 2014, (3 months post-op), radiographs indicated that the inferior plate of the more cranial prosthesis in c5-c6 had migrated anteriorly.Revision surgery occurred on (b)(6) 2014 to remove the device from c5-c6 and perform a plated anterior fusion at that spinal level instead.

Manufacturer Narrative

(b)(4).The reported event has been confirmed via radiograph.Two prostheses were implanted at the c5-c6 and c6-c7 spine levels.The inferior end-plate of the c5-c6 prosthesis appears to have migrated.The explanted device has been returned; evaluation is ongoing at this time.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 patients 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: kim mccaleb ; 7475 lusk boulevard; san diego, CA 92121 ; 8589091980
• MDR Report Key: 4063101
• MDR Text Key: 4812992
• Report Number: 2031966-2014-00046
• 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

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7680372
• Device Lot Number: SV8073
• 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
• Distributor Facility Aware Date: 06/09/2014
• Device Age: 17 MO
• Event Location: Home
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 35 YR