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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
Model Number 48230000
Device Problems Break (1069); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Migration (4003)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 03/28/2018
Event Type  Injury  
Event Description
A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
 
Manufacturer Narrative
The device was returned to stryker on (b)(6) 2018.Sections were updated with product information.
 
Event Description
A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
 
Event Description
A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
 
Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment; result: the blocker was inspected and there was a heavy rod indentation on the bottom of the blocker, indicating excessive tightening torque was applied.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported by the rep that a non stryker torque wrench was used to 12nm and it did not appear that the surgeon applied excessive force.The ifu states that "stryker spine implants may only be implanted with the appropriate instruments supplied by stryker spine".Examination of the implants found that the blockers were heavily deformed on the bottom, which is an indication that more than 12nm of force was applied to the blockers.This can deform the blocker and cause instability in the construct as the blocker is not optimally tightened and seated on the rod, which could cause it to loosen.Conclusion: the most likely root cause is deviation from the surgical technique as a non stryker torque wrench was used to final tighten the blockers.
 
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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
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allendale NJ 07401
MDR Report Key7457895
MDR Text Key106413264
Report Number3005525032-2018-00029
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540560193
UDI-Public(01)04546540560193
Combination Product (y/n)N
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48230000
Device Catalogue Number48230000
Device Lot NumberBD2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Date Manufacturer Received07/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age18 YR
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