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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
Model Number 11090550
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The ex-planted devices were returned and inspected and no product defect or failure was identified. Review of provided radiographs, contact marks and surgeon feedback suggests a combination of installation difficulties and anatomical changeless may have resulted in excessive load and connector separation. Labeling review: ". All set screws should be final-tightened with the counter- torque and torque t-handle. Do not final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip. " ". 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. " ". Care should be taken to insure that all components are ideally fixated prior to closure. All implants should be used only with the appropriately designated instrument. " ". Potential risks identified with the use of this system, which may require additional surgery, include: ¿ bending, fracture or loosening of implant component(s). ".
 
Event Description
It was reported that a implanted asf connector broke at the end to end connection of the two rods. Patient underwent a revision procedure where the construct was extended from t9 to t12 and connected to the existing construct.
 
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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 (Section G)
NUVASIVE INC
7475 lusk blvd
san diego CA 92121
Manufacturer Contact
yobana sanchez
7475 lusk boulevard
san diego, CA 92121
8589093383
MDR Report Key9574672
MDR Text Key182922964
Report Number2031966-2020-00003
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517596420
UDI-Public887517596420
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K143684
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 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11090550
Device Lot NumberAS6583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2018
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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