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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 14; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 14; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Model Number 48557314
Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2017
Event Type  malfunction  
Event Description
It was reported that; oasys system was used on c3-t1 pcf.Surgeon placed all of his screws and decided to take one out.When he tried backing out the screw, the tulip head broke off.He was able to remove the screw shank a few minutes later.
 
Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; visual inspection showed the tulip was confirmed separated from the screw shank.Manufacturing records for this product were reviewed and no anomalies were found.The probable root cause is mis alignment of the screwdriver to the screw axis.
 
Event Description
It was reported that; oasys system was used on c3-t1 pcf.Surgeon placed all of his screws and decided to take one out.When he tried backing out the screw, the tulip head broke off.He was able to remove the screw shank a few minutes later.
 
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Brand Name
OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 14
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 Key7005680
MDR Text Key92093849
Report Number0009617544-2017-00397
Device Sequence Number1
Product Code KWP
UDI-Device Identifier04546540596161
UDI-Public(01)04546540596161
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 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48557314
Device Catalogue Number48557314
Device Lot Number157746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2017
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
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