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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 03828645
Device Problem Fracture (1260)
Patient Problem Injury (2348)
Event Date 05/13/2020
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
It was reported that two xia deformity long arm monoaxial screws fractured post-operatively. Radiography showed that the two screws had fractured and that the patient had fused. Revision surgery was performed and the two screws were successfully removed. This report represents the second of the two screws.
 
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Brand NameXIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM
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 Key10136032
MDR Text Key194625046
Report Number0009617544-2020-00083
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K061854
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03828645
Device Catalogue Number03828645
Device Lot Number166170
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 Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2016
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: 06/09/2020 Patient Sequence Number: 1
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