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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Catalog Number UNK_SPN
Device Problems Detachment Of Device Component (1104); Material Disintegration (1177); Metal Shedding Debris (1804); Material Integrity Problem (2978)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 03/17/2017
Event Type  malfunction  
Event Description
It was reported that " i had a plating system failure after only two years.During my second surgery the surgeon noted that the plate and screws has disintegrated and the my spinal cord was filled with metallosis.I am wondering if you have had other failure with this equipment.I am a young health female and had no other reason for such nonunion and plate disintegration.".
 
Manufacturer Narrative
Risk assessment; device inspection could not be performed as no device was returned.No lot # was provided.The event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.
 
Event Description
It was reported that " i had a plating system failure after only two years.During my second surgery the surgeon noted that the plate and screws has disintegrated and the my spinal cord was filled with metallosis.I am wondering if you have had other failure with this equipment.I am a young health female and had no other reason for such nonunion and plate disintegration.".
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6485479
MDR Text Key72792389
Report Number0009617544-2017-00143
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
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
Date Manufacturer Received03/17/2017
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 Sequence Number1
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