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

Model Number 7680365

Device Problems Failure To Adhere Or Bond (1031); Device Slipped (1584)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Prosthesis was implanted (b)(6) 2013 in the c6-7 disc space; in addition, an acdf was performed at c5-6.In a follow-up visit in (b)(6) 2014, the pcm prosthetic exhibited anterior migration sufficient to require revision.No injury has ben reported, however, the patient reported a return of radicular pain in left arm.

Manufacturer Narrative

(b)(4).The reported event has been confirmed via radiograph.The implant migration may have been precipitated by the patient falling.Shortly after falling, it was noted to have moved approximately 2mm; subsequently reported to have moved approximately 50% out of the disc space anteriorly.Evaluation of the explanted product is in process.No root cause has been identified.Review of the dhr for the lot indicates all specifications have been met during manufacture.Should additional relevant details become available by examining the explanted product, a subsequent report will be filed.

• Brand Name: PCM CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: brett greenwald ; 7475 lusk blvd.; san diego, CA 92121 ; 8583205252
• MDR Report Key: 3925146
• MDR Text Key: 16989212
• Report Number: 2031966-2014-00042
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7680365
• Device Lot Number: SV8121
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2014
• Device Age: 1 YR
• Event Location: Home
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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