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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

Status and location of the device is unknown.

 
Event Description

This record captures a review of 'safety and efficacy of single-stage versus 2-stage spinal fusion via posterior instrumentation and anterior thoracoscopy: a retrospective matched-pair cohort study with 247 consecutive patients' from the journal of world neurosurgery (world neurosurg. /2018) 109:e739-e747. Https. //doi. Org/10. 1016/j. Wneu. 2017. 10. 074). There were 247 patients over 7 years who underwent 1-stage or 2-stage stabilization with thoracoscopic fusion. Forty-seven patients required revision surgery relating to either misplacement/loosening or failure of their mantis, xia, or vlift implants. Additional information is not available at this time, it is not clear which implants experienced failure. This report captures the xia implants.

 
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Brand NameUNKNOWN_SPINE_PRODUCT
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 Key12084704
MDR Text Key258945909
Report Number0009617544-2021-00118
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 06/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SPN
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 Received06/07/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/29/2021 Patient Sequence Number: 1
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