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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
Device Problem Installation-Related Problem (2965)
Patient Problem Laceration(s) (1946)
Event Date 08/23/2021
Event Type  Injury  
Manufacturer Narrative
No product was returned as the device remains in-situ and no malfunction was alleged or identified. The root cause is considered to be a failure to follow the instructions of the surgical technique guide. As review of the reported event states the surgeon broke the extension tabs by hand and failed to utilize the splitting tool as designed allowing his finger to become lacerated. No additional investigation required. Label review ". To break off reduction extensions: insert the mas reduction screw splitting tool into the proximal portion of the reline mas reduction screws, following the same steps outlined in step 2 on page 82. Squeeze the reduction screw splitting tool handles until the screw splits at the top. Repeat until all reduction extensions are split at the top. Grab both reduction extensions and pull medial first, then lateral, until both reduction extensions are removed from the screw. Note: check both reduction extensions after removal for the black lasermark at the distal end of the reduction extension to confirm the reduction extension has broken off at the correct spot (fig. 12). Note: be sure the lock screw is fully seated and the rod is fully reduced prior to breaking off the reduction extensions. Caution be careful when palpating the break point as the tulip may be sharp. " compatibility. All implants should be used only with the appropriately designated instrument (reference surgical technique)¿" information. To obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131. You may also email: info@nuvasive. Com. ".
 
Event Description
On (b)(6) 2021 a patient underwent a maximum access surgery on the t9-l3 levels. It was reported that during the procedure the assistant surgeon lacerated his finger while the tabs off of the reduction screw. The wound was immediately cleansed, and stitches were required. Testing occurred on the assistant surgeon post case that showed no infection. No further information was provided or could be obtained.
 
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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
geoff gannon
7475 lusk boulevard
san diego, CA 92121
MDR Report Key12414658
MDR Text Key272719148
Report Number2031966-2021-00120
Device Sequence Number1
Product Code NKB
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2021
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

Patient Treatment Data
Date Received: 09/02/2021 Patient Sequence Number: 1
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