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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT Back to Search Results
Catalog Number UNK_SPN
Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); No Information (3190)
Event Date 11/11/2015
Event Type  Injury  
Event Description
It was reported that the screw backed out.
 
Manufacturer Narrative
Method: device history review.Complaint history review.Risk assessment.Results: manufacturing review was not performed because no lot number was provided.Conclusion: the plausible root cause of this event is not locking the screws as per the surgical technique.
 
Event Description
It was reported that the screw backed out.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
UNKNOWN SPINE PRODUCT
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5471064
MDR Text Key39381883
Report Number0009617544-2016-00087
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 health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
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? Yes
Date Manufacturer Received11/11/2015
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
Patient Outcome(s) Required Intervention;
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