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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48133236
Device Problems Difficult to Insert (1316); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2020
Event Type  Malfunction  
Event Description

It was reported that two xia titanium 4. 5 polyaxial cross connector securing mechanisms jammed intra-operatively. There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay. This report represents the second of two cross connectors.

 
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Brand NameXIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR 33610
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 Key10072861
MDR Text Key191830661
Report Number0009617544-2020-00070
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
PMA/PMN NumberK121342
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 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48133236
Device Catalogue Number48133236
Device LOT Number1867700
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 Received08/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2018
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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