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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN TRITANIUM ROD; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE UNKNOWN TRITANIUM ROD; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Catalog Number UNK_SPN
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994)
Event Date 03/27/2017
Event Type  malfunction  
Event Description
It was reported that; the patient called indicating that the he saw a memo that stated that the surgeon should not use stryker products in a "patient with dd disease and spinal stenosis".He had the surgery three years ago and recent surgeon has told him that he could potentially be a paraplegic.Patient fell a few times.
 
Manufacturer Narrative
Method: risk assessment.Results: device history review could not be performed as the reported device was not properly identified.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as the reported device was not properly identified.Conclusion: 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; the patient called indicating that the he saw a memo that stated that the surgeon should not use stryker products in a "patient with dd disease and spinal stenosis".He had the surgery three years ago and recent surgeon has told him that he could potentially be a paraplegic.Patient fell a few times.
 
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Brand Name
UNKNOWN TRITANIUM ROD
Type of Device
SPINAL INTERLAMINAL 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 Key6517274
MDR Text Key73732478
Report Number0009617544-2017-00162
Device Sequence Number1
Product Code KWP
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 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_SPN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/27/2017
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
Patient Age53 YR
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