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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 48230000
Device Problems Crack (1135); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2015
Event Type  malfunction  
Event Description
It was reported that, after using the torque wrench on the blocker, the surgeon observe the blocker had cracked entirely from the superior to inferior aspect of the implant.It could not be removed with the blocker inserter as the hex no longer fit.Metal cutters were used to cut the rod, spin out the implant assembly (poly screw, rod, blocker) and new implants replaced.
 
Manufacturer Narrative
Method: device inspection and device history review.Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Inspection of the device revealed deformation of the blocker hex, which suggests that over-torquing of the blocker occurred.Furthermore, the screw tulip is slightly splayed, but the blocker threads line up with the tulip threads, which means that no cross threading occurred.Conclusion: the most likely cause of the customer reported event is over-torquing of the blocker during final tightening.
 
Event Description
It was reported that, after using the torque wrench on the blocker, the surgeon observe the blocker had cracked entirely from the superior to inferior aspect of the implant.It could not be removed with the blocker inserter as the hex no longer fit.Metal cutters were used to cut the rod, spin out the implant assembly (poly screw, rod, blocker) and new implants replaced.
 
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Brand Name
XIA 3 TITANIUM BLOCKER
Type of Device
PEDICLE SCREW SPINAL 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
irma gamonal
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4717062
MDR Text Key5746940
Report Number3005525032-2015-00043
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeAS
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 03/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number48230000
Device Lot NumberJFA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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