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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 8439560
Device Problems Misconnection (1399); Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 12/08/2015
Event Type  Malfunction  
Manufacturer Narrative

No product returned left in-situ. The degree of spinal instability is unknown. Patient's bone quality was unknown. No revision is planned at this time; the patient will continue to be monitored. The root cause of this reported event has not been determined. Labeling review: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); loss of fixation; nonunion or delayed union; fracture of the vertebra; neurological, vascular or visceral injury; metal sensitivity or allergic reaction to a foreign body. Device has not been returned.

 
Event Description

On (b)(6) 2015 a female patients post-operative radiolographs showed the left-side iliac screw components had separated. No additional information has been provided. No injury has been reported.

 
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Brand NameNUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
Manufacturer Contact
george panfili
7475 lusk blvd
san diego, CA 92121
8588825019
MDR Report Key5352213
MDR Text Key35315685
Report Number2031966-2015-00089
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK092287
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 01/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number8439560
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2015
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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