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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 11104055
Device Problem Disconnection (1171)
Patient Problem Failure of Implant (1924)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for investigation nor were radiographs provided to confirm the alleged event. No root cause can be identified at this time. Labeling review: potential adverse events and complications ". As with any major surgical procedures, there are risks involved in orthopedic surgery. Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s). " post-operative warnings ". During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications. " ". Compatibility: do not use the reline system with components of other systems, other than the armada system. Refer to the armada system instructions for use for a list of the armada system indications for use. Unless stated otherwise, nuvasive devices are not to be combined with the components of another system. ".
 
Event Description
A patient underwent a spinal procedure on unknown levels in (b)(6) of 2019. As per reporter, patient began to experience pain and during a routine post-op follow up it was discovered there was a loose connector patient underwent a revision procedure on (b)(6) 2020.
 
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Brand NameNUVASIVE RELINE SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer (Section G)
NUVASIVE INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
dean lucas
7474 lusk boulevard
san diego, CA 92121
MDR Report Key10138798
MDR Text Key194945125
Report Number2031966-2020-00123
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517596246
UDI-Public887517596246
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11104055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/10/2020 Patient Sequence Number: 1
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