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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 24MM POLYAXIAL SCREW; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE OASYS 4.0 X 24MM POLYAXIAL SCREW; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 48552424
Device Problems Break (1069); Device Slipped (1584); Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 02/11/2015
Event Type  Injury  
Event Description
It was reported that, surgeon struggled with advancing oasys screws.Two of screw heads broke off.Surgeon struggled with screwdriver to screw interface on multiple screws.Surgeon struggled with polydriver to engage screw.Surgeon says screws stripped during insertion.Could not back screws out.Had to "helicopter" the stripped screws.8 screws were an issue during procedure.Delay in completing procedure by at least an hour.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the stryker rep reported that the polyaxial screwdriver (pa screwdriver) was firmly attached to the pa screw; however the hex head of the pa screw became stripped, which is only possible if the pa screwdriver is not firmly attached to the pa screw.Conclusion: the probable cause is improper seating of the pa screwdriver onto the pa screw so that the hex head socket fits over the bone screw and threading the end of the outer sleeve into the pa screw head for stable fixation as outlined in the surgical technique.
 
Event Description
It was reported that, surgeon struggled with advancing oasys screws.Two of screw heads broke off.Surgeon struggled with screwdriver to screw interface on multiple screws.Surgeon struggled with polydriver to engage screw.Surgeon says screws stripped during insertion.Could not back screws out.Had to "helicopter" the stripped screws.8 screws were an issue during procedure.Delay in completing procedure by at least an hour.
 
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Brand Name
OASYS 4.0 X 24MM POLYAXIAL SCREW
Type of Device
PEDICLE SCREW SPINAL SYSTEM
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 Key4571848
MDR Text Key5549883
Report Number0009617544-2015-00106
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032394
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 02/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number48552424
Device Lot Number142132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2015
Initial Date FDA Received03/05/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/06/2014
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 Outcome(s) Other;
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