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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 70MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 70MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 4823718570
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Fall (1848); Injury (2348); Foreign Body In Patient (2687)
Event Date 07/28/2018
Event Type  Injury  
Manufacturer Narrative
Device still in the patient.
 
Event Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient. Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed. Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.
 
Manufacturer Narrative
Nc/capa history review, labelling review, risk assessment the reported event was confirmed via correspondence with sales rep. No lot # was provided, so a manufacturing record review and complaint history review could not be performed. Product was not returned so an evaluation was not possible. Nc/capa history review revealed no relevant nc/capa. Due to lack of information and no product return, root cause of the reported event could not be determined conclusively. Potential causes include but not limited to: - excessive torque applied to final tighten blocker resulting in unstable construct - application of excessive force - anti-torque key not used - universal tightener used to final tighten - force from rod pushes blocker out of tulip (insufficient rod persuasion) - incorrect assembly of anti-torque key and torque wrench device is still remained implanted int the patient.
 
Event Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient. Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed. Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.
 
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Brand NameXIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 70MM
Type of DeviceTHORACOLUMBOSACRAL 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
CH 2300
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8178467
MDR Text Key130783529
Report Number3005525032-2018-00079
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4823718570
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
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