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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48133200
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2018
Event Type  Injury  
Event Description
It was reported rod was broken post-operatively. As per the email communication with rep, the revision surgery was planned on (b)(6) 2018.
 
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Brand NameXIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200
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 Key8178558
MDR Text Key130785156
Report Number0009617544-2018-00302
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K121342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2019
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 Number48133200
Device Lot NumberM4R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
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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