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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE AFFIX SPINAL INTERLAMINAL FIXATION ORTHOSIS

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NUVASIVE AFFIX SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
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.
 
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Brand NameAFFIX
Type of DeviceSPINAL 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 Key8893746
MDR Text Key154321157
Report Number2031966-2019-00226
Device Sequence Number1
Product Code PEK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/17/2019
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

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