MAUDE Adverse Event Report: NUVASIVE, INC. X-CORE VERTEBRAL BODY REPLACEMENT DEVICE; SPINAL VERTEBRAL BODY REPLACEMENT

Model Number 7220079

Device Problems Collapse (1099); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Vertebral body replacement device was placed following a corpectomy of the l3 and l4 levels that was performed on (b)(6) 2014.In (b)(6) 2014 patient felt pain after sustaining a fall.During follow up visit, it was noted from radiographs that the end-cap had disassociated itself along with height reduction.Revision surgery was performed on (b)(6) 2015.

Manufacturer Narrative

(b)(4).The radiographs were received and the event was confirmed.The vertebral body replacement device had partially collapsed.Visual inspection of the explant noted marks consistent with set screw tightening; one end-cap screw was also damaged and the other had loosened which led to the end-cap separating from the implant core.Root cause of the event has not been established at this time.Review of the device history records notes no material non-conformances of manufacturing errors that may have caused or contributed to this mode of failure.Review of labeling notes: internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.

• Brand Name: X-CORE VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: deborah silva ; 7475 lusk blvd; san diego, CA 92121 ; 8589091830
• MDR Report Key: 4438224
• MDR Text Key: 19767964
• Report Number: 2031966-2014-00092
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090176
• 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: 01/14/2015

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: 7220079
• Device Lot Number: DR3541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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
• Patient Age: 63 YR