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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 35MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 35MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number 03829630
Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2017
Event Type  malfunction  
Event Description
It was reported that; during the operation, the universal screw was implanted and the nail head was unable to operate and the screws were not implanted properly.Additional information noted the following; it would have been necessary to implant 6 screws.But in the end, only 5 screws were fixed to perform the operation.
 
Manufacturer Narrative
Visual analysis; device history review; complaint history review; risk assessment; the tulip head was found to have partially disengaged from the screw.Manufacturing records were reviewed for the corresponding lot, and no relevant issues were identified.The plausible root causes include the application of excessive force, the application of off-axis loading, and the screw not securely engaged with the screwdriver.
 
Event Description
It was reported that; during the operation, the universal screw was implanted and the nail head was unable to operate and the screws were not implanted properly.Additional information noted the following; it would have been necessary to implant 6 screws.But in the end, only 5 screws were fixed to perform the operation.
 
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Brand Name
XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 35MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
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
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6655094
MDR Text Key78143059
Report Number0009617544-2017-00253
Device Sequence Number1
Product Code MNH
UDI-Device Identifier07613154407866
UDI-Public(01)07613154407866
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K061854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number03829630
Device Catalogue Number03829635
Device Lot Number157351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received05/25/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/27/2015
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 Weight52
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