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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 8252500006
Device Problems Fracture (1260); Osseointegration Problem (3003)
Patient Problem Failure of Implant (1924)
Event Date 04/25/2017
Event Type  malfunction  
Manufacturer Narrative
The explanted materials were discarded at the facility post-op and will not be returned for further evaluation. The surgeon commented that since the patient was very active after surgery, it may have resulted in rod fracture. The root cause is not known. ". Contraindications include but are not limited to. Patients who are unwilling to restrict activities or follow medical advice. " ". 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. " ". These devices can break when subjected to the increased load associated with delayed union or nonunion. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " ". The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components. The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed. " device was discarded at the facility.
 
Event Description
On (b)(6) 2016 a patient underwent a vertebral body replacement. On (b)(6) 2016 posterior fixation was performed using a deformity system and peek spacer. Revision surgery was performed on (b)(6) 2017 due to rod fracture, malalignment and incomplete bone union. The fractured rods were replaced and additional fixation was performed.
 
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Brand NameNUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
dean lucas
7475 lusk blvd
san diego, CA 92121
8586385546
MDR Report Key6577366
MDR Text Key75512619
Report Number2031966-2017-00055
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092287
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8252500006
Device Lot NumberCT39999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2015
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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