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

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

Patient Problem Pain (1994)

Event Date 11/23/2013

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 properly fused.No product returned.

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.

• Brand Name: AFFIX PLATE
• 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 CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 8893763
• MDR Text Key: 154546765
• Report Number: 2031966-2019-00227
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• 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
• Patient Outcome(s): Hospitalization