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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 6.5X60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482804660
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 03/13/2018
Event Type  Injury  
Event Description
It was reported that a patient underwent an endoscope posterior fixation of th9 - l2.The surgical procedure was completed smoothly, but after reviewing the x ray, the tab of the right screw was not properly broken and remained in patient's body.Only the relevant part was then opened in the icu to break the tab off the screw and out of the patient's body.Removal was successful.
 
Manufacturer Narrative
Results: visual, dimensional and functional analysis could not be performed as the device was not returned.Two potential lot numbers were provided, since the device was not return the investigation could not determine what lot was used in the surgery.Manufacturing records were reviewed for both lot numbers and no relevant issues were identified.Conclusion: per what was reported, the user did not correctly seat the blade remover onto the blade.If the user does not fully seat blade remover on blades and applies load on weld, blade can break at weld and reduction tab remains on screw.The probable root cause of the reported event was determined to be user error.
 
Event Description
It was reported that a patient underwent an endoscope posterior fixation of th9 - l2.The surgical procedure was completed smoothly, but after reviewing the x ray, the tab of the right screw was not properly broken and remained in patient's body.Only the relevant part was then opened in the icu to break the tab off the screw and out of the patient's body.Removal was successful.
 
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Brand Name
ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM
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
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7402146
MDR Text Key104530805
Report Number0009617544-2018-00078
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327002362
UDI-Public(01)07613327002362
Combination Product (y/n)N
PMA/PMN Number
K122845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number482804660
Device Catalogue Number482804660
Device Lot Number176186 OR 17D660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/29/2018
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 Sequence Number1
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