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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48230000
Device Problems Break (1069); Fracture (1260); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2017
Event Type  malfunction  
Event Description
It was reported that; during surgeons' second surgery, while final tightening the last blocker during revision case on l1, the torque wrench slipped wouldn't line to 12nm.Removed the anti torque key and saw that the blocker had broken in the tulip with rod already in.Surgeon tried to remove the broken blocker but ultimately had to use a drill to retrieve the blocker.Surgeon then went to insert a new blocker.However the same issue occurred.The arrows wouldn't go line to line.The counter torque was removed and it was noticed that the blocker had broke again.There were no adverse consequences to the patient.The surgery was delayed 30min.The surgery was successfully completed using a different torque limiting tightener.The revision surgery was due to an extension of a construct.
 
Event Description
It was reported that; during surgeons' second surgery, while final tightening the last blocker during revision case on l1, the torque wrench slipped wouldn't line to 12nm.Removed the anti torque key and saw that the blocker had broken in the tulip with rod already in.Surgeon tried to remove the broken blocker but ultimately had to use a drill to retrieve the blocker.Surgeon then went to insert a new blocker.However the same issue occurred.The arrows wouldn't go line to line.The counter torque was removed and it was noticed that the blocker had broke again.There were no adverse consequences to the patient.The surgery was delayed 30min.The surgery was successfully completed using a different torque limiting tightener.The revision surgery was due to an extension of a construct.
 
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Brand Name
XIA 3 TITANIUM BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH  2300
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 Key7005682
MDR Text Key92488768
Report Number3005525032-2017-00102
Device Sequence Number1
Product Code MNI
UDI-Device Identifier04546540560193
UDI-Public(01)04546540560193
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48230000
Device Catalogue Number48230000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Weight134
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