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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SCREW AND ROD FIXATION SYSTEM 5.5 SPINAL SYSTEM

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NUVASIVE NUVASIVE RELINE SCREW AND ROD FIXATION SYSTEM 5.5 SPINAL SYSTEM Back to Search Results
Device Problems Break (1069); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2016
Event Type  Malfunction  
Event Description

During routine posterior lumbar fusion l4-5 a final lockdown of the set screws for the inserted 4 pedicle screws is required using a torque wrench screw driver. The first 3 screws locked down without difficulties, in the final one the screwdriver broke off in the set screw. Efforts at either removing the broken screw driver tip from the set screw or to remove the while set screw were unsuccessful, requiring us to cut the rod, removing the screw assembly and exchanging the affected screw and then implanting a new rod. The pt was not harmed, but the surgery took about 60 minutes longer than expected. The defective screw driver and screw assembly was sent to the pathology department for identification and evaluation. Diagnosis or reason for use: l4-5 spondylolisthesis.

 
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Brand NameNUVASIVE RELINE SCREW AND ROD FIXATION SYSTEM 5.5
Type of DeviceSPINAL SYSTEM
Manufacturer (Section D)
NUVASIVE
sand diego CA
MDR Report Key5781763
MDR Text Key49255471
Report NumberMW5063316
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/06/2016 Patient Sequence Number: 1
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