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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Catalog Number 48811114
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2016
Event Type  malfunction  
Event Description
It was reported that they were doing an acdf with plating and that when placing the screws into the plate, the silver locking wing on the plate appeared to deform.The surgeon did not want to continue using this particular plate, so swapped it for a new one of the same size and make.Update: the surgeon further reported that he put the screw in and then wanted to reposition it.When he tried to remove the screw, it had gone past the locking mechanism and broke as it was taken out.He said he broke the wing on the plate.The screw did not break.
 
Manufacturer Narrative
Method: vidual inspection, device history review, complaint history review, risk assessment; result: the device was confirmed visually to have a deformed spring bar.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable root cause of the mechanism popping up is not determined and multifactorial.
 
Event Description
It was reported that they were doing an acdf with plating and that when placing the screws into the plate, the silver locking wing on the plate appeared to deform.The surgeon did not want to continue using this particular plate, so swapped it for a new one of the same size and make.Update: the surgeon further reported that he put the screw in and then wanted to reposition it.When he tried to remove the screw, it had gone past the locking mechanism and broke as it was taken out.He said he broke the wing on the plate.The screw did not break.
 
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Brand Name
AVIATOR ASSY ONE LEVEL PLATE SIZE 14
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
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6120193
MDR Text Key60934122
Report Number0009617544-2016-00473
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier07613252152118
UDI-Public(01)07613252152118
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K083562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48811114
Device Lot Number168528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/31/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/12/2016
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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