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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 Failure to Align (2522); Migration (4003)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 09/02/2016
Event Type  Injury  
Event Description

It was reported that the right side screw is not lined up with left side and it is poking through anterior sacrum almost 3 threads. The patient allegedly become disabled with entire body pain and spinal pain throughout.

 
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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
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8081374
MDR Text Key127532314
Report Number0009617544-2018-00269
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNK_SPN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated By Manufacturer? No
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: 11/16/2018 Patient Sequence Number: 1
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