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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.5 X 35 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.5 X 35 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 488515535
Device Problem Fracture (1260)
Patient Problem Injury (2348)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported that a tritanium pl cage and a xia ct polyaxial cortical screw, implanted at l5-s1, fractured post-operatively. Fusion was not achieved. Revision surgery will occur to replace devices. This report captures the screw.
 
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Brand NamePOLYAXIAL CORTICAL SCREW 5.5 X 35
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
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key10125323
MDR Text Key194644972
Report Number0009617544-2020-00080
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152632
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number488515535
Device Catalogue Number488515535
Device Lot NumberUNKNOWN
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 Received07/30/2020
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: 06/05/2020 Patient Sequence Number: 1
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