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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482804745
Device Problem Material Separation (1562)
Patient Problem Unspecified Infection (1930)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
A company representative reported that a patient implanted with es2 pedicle screws for a one level lumbar fusion presented with a surgical infection approximately one-month post-operatively.During removal of the implanted hardware it was discovered that tulip of an es2 long blade cannulated screw had disengaged.The tulip of the screw was explanted but the shaft of the screw was unable to be removed and was left in the pedicle.
 
Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
 
Event Description
A company representative reported that a patient implanted with es2 pedicle screws for a one level lumbar fusion presented with a surgical infection approximately one-month post-operatively.During removal of the implanted hardware it was discovered that tulip of an es2 long blade cannulated screw had disengaged.The tulip of the screw was explanted but the shaft of the screw was unable to be removed and was left in the pedicle.
 
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Brand Name
ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key16857579
MDR Text Key314455331
Report Number0009617544-2023-00019
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327002232
UDI-Public07613327002232
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number482804745
Device Catalogue Number482804745
Device Lot Number178045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received07/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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