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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 6.5X50MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482804650
Device Problems Break (1069); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
Patient Problem Injury (2348)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: device discarded by the hospital.
 
Event Description
The surgeon notified stryker of a revision which took place (b)(6) 2019 to replace a broken es2 integrated blade screw implanted at 4-1 level.
 
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Brand NameES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM
Type of DeviceTHORACOLUMBOSACRAL 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
margarita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8811604
MDR Text Key151742059
Report Number0009617544-2019-00089
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327002195
UDI-Public07613327002195
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number482804650
Device Lot Number17E090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2019
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: 07/22/2019 Patient Sequence Number: 1
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