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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. NUVASIVE RELINE MAS REDUCTION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 16027540
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  Injury  
Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer. No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique. A definitive root cause was unable to be determined with the information provided. Labeling review: "warnings, cautions and precautions: the safety and effectiveness of these devices for any other conditions are unknown. The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient" "care should be used in the handling and storage of the reline implants. The implants should not be scratched or damaged. Implants and instruments should be protected during storage and from corrosive environments" "inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier. Do not use the reline implants if there is any evidence of damage" "the silencer and gator reducers are not compatible with reduction screws or reduction uni-planar screws and may damage the implant if used. Only the matador reducer and rocker may be used" "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" if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
 
Event Description
It was reported that the patient underwent an initial posterior fixation procedure utilizing percutaneous pedicle screws. During the procedure, following implantation of the pedicle screw, the locking screw was unable to be delivered into the reduction screw tulip. Several lock screws were attempted and none were able to fit. The procedure was converted to an open approach to complete the fixation. No patient harm or further patient impact was reported.
 
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Brand NameNUVASIVE RELINE MAS REDUCTION SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk boulevard
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INC.
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
geoff gannon
7475 lusk boulevard
san diego, CA 92121
MDR Report Key14743962
MDR Text Key295019856
Report Number2031966-2022-00114
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517556981
UDI-Public887517556981
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16027540
Device Catalogue NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2022
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/20/2022 Patient Sequence Number: 1
Treatment
UNK LOCK SCREW
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