MAUDE Adverse Event Report: NUVASIVE AFFIX; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor alleged product malfunction reported.At this time no root cause can be confirmed.As per reporter spine was never fused.

Event Description

On (b)(6) 2013, patient underwent spine procedure.As per information received patient underwent re-exploration procedure on (b)(6) 2014 and placement of a affix product was performed.On (b)(6) 2015 patient underwent a hemilaminectomy and placement of an affinity plate.

• Brand Name: AFFIX
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 8893746
• MDR Text Key: 154321157
• Report Number: 2031966-2019-00226
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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