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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; IMPLANT-SCREW
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STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; IMPLANT-SCREW Back to Search Results
Catalog Number 48558312
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2014
Event Type  malfunction  
Event Description
It was reported that a non-biased poly screw was used in a posterior cervical where the screw's head could not be adjusted after implantation for poly axial movement.The surgeon had to remove the screw and implant another one.
 
Manufacturer Narrative
Method: device history review, visual and functional inspection.Results: manufacturing files were reviewed and no incidents were found.Visual inspection found to have a tulip that was jammed into the screw shank.The tulip was able to be freed from the jammed position.Functional inspection indicated the tulip was able to be freed from the jammed position.The tulip was reinstalled on the polyaxial screwdriver, the sleeve severely tightened down and the reported failure mode was able to be repeated.Conclusion: it was not known if the screws were inserted tightly against the vertebral body and/or if it was overtightened in the polyaxial screwdriver which caused the head to fuse with the screw shank so the cause is multifactorial.
 
Event Description
It was reported that a non-biased poly screw was used in a posterior cervical where the screw's head could not be adjusted after implantation for poly axial movement.The surgeon had to remove the screw and implant another one.
 
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Brand Name
OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12
Type of Device
IMPLANT-SCREW
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4246176
MDR Text Key5104666
Report Number0009617544-2014-00472
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072568
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 10/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48558312
Device Lot Number146458
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/10/2014
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 Age75 YR
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