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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE® RELINE® SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INC. NUVASIVE® RELINE® SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Failure of Implant (1924)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for investigation. Review of the reported event, torque test results and radiograph provided suggest operational context may have caused or contributed to the event. 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. " ". All lock screws should be final-tightened with the counter-torque and torque t-handle. Do not final tighten through compression instruments (e. G. C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip. Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw. The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct. The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct. " ". Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size of the implant. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Metallic and internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone. 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. ".
 
Event Description
As per reporter patient underwent an extreme lateral interbody fusion procedure with a lateral plate and posterior fixation at s3-l4 without any reported issues. On (b)(6) 2018 follow up radiographs showed a rod separation at s1 level. It is unknown when index procedure occurred. No revision procedure is planned at this time. No patient injury reported.
 
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Brand NameNUVASIVE® RELINE® SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
Manufacturer Contact
george panfili
7475 lusk blvd
san diego, CA 92121
8588825019
MDR Report Key7558842
MDR Text Key109899421
Report Number2031966-2018-00089
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160989
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 05/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received05/04/2018
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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