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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA II VITALIUM ROD 6.0 MM X 600 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA II VITALIUM ROD 6.0 MM X 600 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 03822601
Device Problems Break (1069); Fracture (1260)
Patient Problems Fall (1848); Injury (2348)
Event Date 07/28/2018
Event Type  Injury  
Manufacturer Narrative
Device still in the patient.
 
Event Description
It was reported that the patient fell in (b)(6) 2018, causing rod to break. No adverse consequence to the patient was reported. The revision surgery will be performed to replace rod.
 
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Brand NameXIA II VITALIUM ROD 6.0 MM X 600 MM
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 NJ 33610
FR 33610
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8178465
MDR Text Key130783460
Report Number3004024955-2018-00059
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03822601
Device Lot NumberSFB
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 Received01/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2016
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: 12/19/2018 Patient Sequence Number: 1
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