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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 03756230
Device Problems Device Slipped (1584); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2018
Event Type  malfunction  
Event Description
It was reported that during surgery, screws slips off after tighten hexagon thread using crown-opener.Trying to loosen it and re-installed would occur a problem that hexagon thread becoming too slippery to install.Surgery was successfully completed using back-up blockers.Surgical delay of 5 min was reported.No adverse consequence to the patient was reported.
 
Event Description
It was reported that during surgery, screws slips off after tighten hexagon thread using crown-opener.Trying to loosen it and re-installed would occur a problem that hexagon thread becoming too slippery to install.Surgery was successfully completed using back-up blockers.Surgical delay of 5 min was reported.No adverse consequence to the patient was reported.
 
Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with sales rep.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Product was not received back so an evaluation was not possible.Upon complaint history review and nc/capa history review, no relevant complaints/ nc/capa were identified.It was reported that the blocker appeared to be cross-threaded with the tulip head.Conclusion: the most likely cause of the reported event was determined to be cross threading of blocker with tulip head resulting in difficult assembly.Device not returned.
 
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Brand Name
XIA BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8094226
MDR Text Key128270165
Report Number3005525032-2018-00073
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540147257
UDI-Public04546540147257
Combination Product (y/n)N
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number03756230
Device Lot Number9Y4
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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