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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 6.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA LP POLYAXIAL SCREW 6.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 03821650
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
It was reported that the tulip of a xia ii lp polyaxial screw disengaged intra-operatively.Surgery was successfully completed with another screw and no delay.No adverse consequences or medical intervention were reported.
 
Event Description
It was reported that the tulip of a xia ii lp polyaxial screw disengaged intra-operatively.Surgery was successfully completed with another screw and no delay.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
A visual inspection was performed and found the underside of the tulip to be deformed.Proximal threads are deformed.A functional inspection performed found that the tulip is jammed and has lost all ability to articulate on the screw shank.Tulip is too proximal on the shank, evidence of screw being inserted too far.Location of tulip deformation indicates screw was most likely inserted too far and the base of the tulip became jammed on bone.The bone may have caused the tulip to disengage.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot and subject catalog number, and no adverse trends were observed.The customer reported an event of a xia ii lp polyaxial screw tulip jamming intra-op which was confirmed via visual and functional inspection.Initial report states that once the screw was inserted into the patient the tulip was jammed and could not be moved.The surgeon attempted to remove the screw and the tulip disengaged from the screw shank.The xia surgical technique was reviewed: ¿with the pedicle pathways prepared and proper screw length and diameter determined, the screw is prepared for insertion.¿ note: ¿the poly axial screws may lock upon insertion.Use the inserter to unlock the heads before introducing the rod.¿ the most likely cause of the reported event was determined to be due to screw tulip contacting bone during insertion.Over insertion of screws can cause the tulip to jam on the bone.Contact from the bone can cause tulip to disengage.
 
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Brand Name
XIA LP POLYAXIAL SCREW 6.5 X 50MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
SZ   2300
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key13904721
MDR Text Key288482731
Report Number3005525032-2022-00011
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540149251
UDI-Public04546540149251
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060361
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 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03821650
Device Catalogue Number03821650
Device Lot NumberC08509
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/25/2022
Initial Date FDA Received03/25/2022
Supplement Dates Manufacturer Received05/18/2022
Supplement Dates FDA Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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