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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM TRANSVERSE PROCESS HOOK LEFT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA 3 TITANIUM TRANSVERSE PROCESS HOOK LEFT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48230233
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
A physician reported that while attempting to install a xia 3 titanium transverse process hook on the left t11, the patient's transverse process broke. The physician altered their surgical plan and the operation was completed successfully using a pedicle screw.
 
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Brand NameXIA 3 TITANIUM TRANSVERSE PROCESS HOOK LEFT
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 Key9934170
MDR Text Key186823996
Report Number0009617544-2020-00056
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K142381
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 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number48230233
Device Catalogue Number48230233
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 Received05/30/2020
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: 04/08/2020 Patient Sequence Number: 1
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