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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 35 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 35 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48146535
Device Problems Break (1069); Detachment of Device or Device Component (2907); Migration (4003)
Patient Problems Dyspnea (1816); Fall (1848); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
Event Date 05/16/2018
Event Type  Injury  
Event Description
It was reported that the rod broke in half and screws came out post-operatively. Patient reportedly had fall in (b)(6) of 2017 in which she tripped over a chair and fell on their knees. The patient was in pain, couldn't walk, trouble breathing and couldn't lift arm. The patient underwent revision surgery on (b)(6) 2018 to replace hardware.
 
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Brand NameXIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 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
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8139682
MDR Text Key129572183
Report Number0009617544-2018-00291
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48146535
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? No
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: 12/06/2018 Patient Sequence Number: 1
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