Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; IMPLANT-SCREW
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; IMPLANT-SCREW Back to Search Results
Catalog Number 48552314
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, surgery was performed.C1-2 was fixed.When the surgeon tried the final tightening, c1 screw was cut out from the bone.For replace, the surgeon extracted the implants.But it was difficult to remove the blocker on c1 from the screw, and head of the screw was fixed.Because it was impossible to replace the implants, new implants were used and fixed the patient bone.
 
Manufacturer Narrative
Method: device history review and visual inspection.Results: manufacturing files were reviewed and no incidents were found.Visual inspection of the returned device was examined and found to have a tulip jammed into the shank of the threaded screw.Conclusion: the patients bone quality was reported as brittle (hard) and therefore the probable root cause is brittle paitent bone quality due to the extra torque required to install the screw into the vertebral body and the difficulty in adjusting the polyaxial screw during construct installation.
 
Event Description
On (b)(6) 2014, surgery was performed.C1-2 was fixed.When the surgeon tried the final tightening, c1 screw was cut out from the bone.For replace, the surgeon extracted the implants.But it was difficult to remove the blocker on c1 from the screw, and head of the screw was fixed.Because it was impossible to replace the implants, new implants were used and fixed the patient bone.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OASYS 3.5 X 14MM POLYAXIAL SCREW
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 Key4277231
MDR Text Key5300099
Report Number0009617544-2014-00497
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeJA
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 11/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48552314
Device Lot Number13F340
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/16/2013
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 Age83 YR
-
-