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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE SPINE, INC. NAUTILUS PEDICLE SCREW FIXATION

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LIFE SPINE, INC. NAUTILUS PEDICLE SCREW FIXATION Back to Search Results
Model Number 116-536
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
The product wasn't retuned as part of the k-wire was retained in the patient. From the xray images received the kwire is perpendicular to the screw, so without further information we are unable to determine the cause of the kwire breaking.
 
Event Description
K-wire threaded tip broke off in patient si pedicle.
 
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Brand NameNAUTILUS
Type of DevicePEDICLE SCREW FIXATION
Manufacturer (Section D)
LIFE SPINE, INC.
13951 s. quality drive
huntley IL 60142
Manufacturer (Section G)
LIFE SPINE, INC.
13951 s. quality drive
huntley IL 60142
Manufacturer Contact
angela batker
13951 s. quality drive
huntley, IL 60142
MDR Report Key9618307
MDR Text Key176367325
Report Number3004499989-2020-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number116-536
Device Catalogue Number116-536
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/02/2020
Event Location Hospital
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2020 Patient Sequence Number: 1
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