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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48230000
Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problem Injury (2348)
Event Date 10/21/2019
Event Type  Injury  
Event Description
It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the migrated blocker.
 
Event Description
It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the migrated blocker.
 
Manufacturer Narrative
Visual inspection: there were no rod indentations on the bottom of the blocker indicating that the blocker was under-tightened.Functional inspection: the blocker was able to be threaded into a test screw.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.From the xia 3 surgical technique once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Examination of the blocker found that there were no rod indentations on the bottom of the blocker, which would be expected for a blocker tightened to 12nm.This indicates that the blocker was under-tightened and most likely the reason why it migrated or loosened out of the tulip.
 
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Brand Name
XIA 3 TITANIUM BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key9298097
MDR Text Key166376791
Report Number0009617544-2019-00122
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540560193
UDI-Public04546540560193
Combination Product (y/n)N
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48230000
Device Lot Number63W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Date Manufacturer Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age11 YR
Patient Weight67
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