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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482318570
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem Pain (1994)
Event Date 08/06/2021
Event Type  Injury  
Event Description
It was reported that a patient experienced pain and imaging revealed a fractured xia lp polyaxial screw, a fractured xia rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's illium.This report captures the xia 3 titanium polyaxial screw.
 
Manufacturer Narrative
D6b: date of explant, was corrected from "(b)(6) 2021" to "(b)(6) 2021".Visual, dimensional, material and functional analysis could not be performed as the device was not returned manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.Review of x-ray reveals the following.Rod fracture is observed between l4/l5 screw on the patients right side.The iliac screw on the left side attached to the main rod fractured at the head of the screw.This screw shank was unable to be removed.The tulip of the adjacent iliac screw, which is attached by an extender to l1 space, appears to have disengaged from the screw shank.This shank was able to be removed and replaced with a new screw.Additionally, the right l2 screw was removed to make space for a rod extender connecting a new iliac screw on the right.A new iliac screw was added between the 2 existing iliac screws on the left side, and connected to the main rod.The xia ii lp polyaxial screw device ifu were reviewed: these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.The most likely cause of the reported event was determined to be due to the age of device implantation.After one year, fusion is expected and was achieved, therefore the devices served their intended purpose.Due to rod and screw fractures/disengagement occurring on opposite sides, but similar levels, it is potential that a fall/external event may have contributed to the event.However, this cannot be confirmed as it was reported that no external trauma was experienced.H3 other text: no product returned.
 
Event Description
It was reported that a patient experienced pain and imaging revealed a fractured xia lp polyaxial screw, a fractured xia rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's illium.This report captures the fractured xia polyaxial screw.
 
Manufacturer Narrative
H6 coding has been updated to reflect device evaluation and investigation conclusion.
 
Event Description
It was reported that a patient experienced pain and imaging revealed a fractured xia ii lp polyaxial screw, a fractured xia ii rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's ilium.This report captures the xia 3 titanium polyaxial screw.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
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 Key12407821
MDR Text Key269371132
Report Number3005525032-2021-00037
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540598646
UDI-Public04546540598646
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number482318570
Device Catalogue Number482318570
Device Lot NumberB84540
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received10/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2018
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;
Patient Age11 YR
Patient SexMale
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