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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; SPINAL INTERLAMINAL FIXATION ORTHOSIS.
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STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; SPINAL INTERLAMINAL FIXATION ORTHOSIS. Back to Search Results
Catalog Number 48558312
Device Problems Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2016
Event Type  Injury  
Event Description
It was reported that a screw on the left at c5 had to be removed, after removing blocker and getting rod out of the way, the surgeon was unable to access the screw head due to it being cold fused.Rocked screw back and forth too much, then used an alternative instrument and pulled screw out.This was not ideal and surgeon requested i send screw in to be analyzed.
 
Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the screw was examined and found to have a tulip head that was jammed into the screw shank.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable cause is patient factors due to the screw being implanted and a constant force applied to the tulip head jamming it into the shank.
 
Event Description
It was reported that a screw on the left at c5 had to be removed, after removing blocker and getting rod out of the way, the surgeon was unable to access the screw head due to it being cold fused.Rocked screw back and forth too much, then used an alternative instrument and pulled screw out.This was not ideal and surgeon requested i send screw in to be analyzed.
 
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Brand Name
OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12
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 Key6196350
MDR Text Key63068025
Report Number0009617544-2016-00500
Device Sequence Number1
Product Code KWP
UDI-Device Identifier04546540596314
UDI-Public(01)04546540596314
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 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48558312
Device Lot Number161490
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/19/2016
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) Required Intervention;
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