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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482316540
Device Problems Screw (568); Break (1069); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/11/2018
Event Type  Malfunction  
Event Description

It is reported that during a revision surgery a screw broke. The broken screw was left inside the patient. Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1. No adverse consequences has been reported due to screw breakage.

 
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Brand NameXIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 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 33610
FR 33610
Manufacturer Contact
margarita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7572788
MDR Text Key110461792
Report Number0009617544-2018-00135
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
PMA/PMN NumberK113666
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 09/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number482316540
Device LOT NumberB53478
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/20/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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