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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482316540
Device Problems Break (1069); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/11/2018
Event Type  malfunction  
Event Description
It is reported that during a revision surgery a screw broke.The broken screw was left inside the patient.Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1.No adverse consequences has been reported due to screw breakage.
 
Event Description
It is reported that during a revision surgery a screw broke.The broken screw was left inside the patient.Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1.No adverse consequences has been reported due to screw breakage.
 
Manufacturer Narrative
Method: visual inspection, material analysis, product history review, complaint history review, labelling review, risk assessment.Result: the customer reported event was confirmed via visual inspection and x ray.The returned screw was fractured at the screw shank.The fractured piece was not returned.Device was sent for material analysis.The fractured screw was visually consistent with a fatigue fracture.The fracture surface was too damaged post fracture to determine the exact mode.The elemental constituents were consistent with the print.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the screw was implanted in (b)(6) 2015.According to the ifu, "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred." conclusion: the most likely root cause is fatigue fracture due to length of implantation.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7572788
MDR Text Key110461792
Report Number0009617544-2018-00135
Device Sequence Number1
Product Code OSH
UDI-Device Identifier04546540562234
UDI-Public04546540562234
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
Type of Report Initial,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number482316540
Device Lot NumberB53478
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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