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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 4.5 X 32; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Catalog Number 48558532
Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 04/19/2016
Event Type  Injury  
Event Description
It was reported that; the tulip head broke off of screw at t1.The other screw also at t1 was stripped and unable to be removed or advanced further.Update (26-apr-2016): the stripped screw remains in patient.The detached tulip forced him to add extra level which added 45 min to case.
 
Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no anomalies were found.The stryker rep reported that the patient had hard bone quality, that proper prep of the screw holes was completed and that the polyaxial screw was properly attached to a polyaxial screwdriver (as per stg).Conclusion: the possible root causes for the tulip separation include: screw misaligned for angular insertion into bone, hard bone and screw connected too tight to screw driver, however the exact root cause of the tulip disengagement is not determined.
 
Event Description
It was reported that; the tulip head broke off of screw at t1.The other screw also at t1 was stripped and unable to be removed or advanced further.Update (26-apr-2016): the stripped screw remains in patient.The detached tulip forced him to add extra level which added 45 min to case.
 
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Brand Name
OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32
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 Key5661383
MDR Text Key45368650
Report Number0009617544-2016-00190
Device Sequence Number1
Product Code KWP
UDI-Device Identifier04546540596451
UDI-Public(01)04546540596451
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151755
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 04/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48558532
Device Lot Number160126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received04/20/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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