MAUDE Adverse Event Report: NUVASIVE, INC. SPINOUS PROCESS PLATE SYSTEM; SPINAL INTERLAMINAL FIXATION ORTHOSI

Model Number 7577045

Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 06/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Radiographs confirming the event were received.In comparison to immediate post operative radiographs and 6 week post operative radiographs, the device has week post operative radiographs, the device has loosened/decompressed/opened approximately 2mm, but remains fixated and has not migrated.Review of dhr for lot tu3789 notes no discrepancies with respect to material type, treatments, dimensions nor labeling.No revision has occurred and the device remains in the patient.No product will be returned and no further evaluation of the product can be completed at this time.It is unknown if the device was fully fixated and in the locked position.Patient activity at the time or prior to the event is unknown.Patient's bone quality is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained an impact of some sort.The root cause of the issue remains unknown.

Event Description

On (b)(6) 2015, interlaminar fusion surgery to decompress and fuse l4-l5 involving interlaminar graft and plating system.During routine follow up, 6-7 weeks post operatively, it was noted that the plate had loosened.The patient is asymptomatic.There has been no change to patient therapy and surgeon elects to monitor patient.

• Brand Name: SPINOUS PROCESS PLATE SYSTEM
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSI
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4913350
• MDR Text Key: 22394953
• Report Number: 2031966-2015-00036
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K073278
• 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: 07/09/2015

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: 7577045
• Device Lot Number: TU3789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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