XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM NA

Adverse Event reported on 11/14/2012

Device Attributes
AttributeValue
ManufacturerSTRYKER SPINE BORDEAUX
Brand NameXIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
Device TypeIMPLANT
Product CodeNKB
Model NumberNA
Catalog Number482317540
Device Operator0HP
STRYKER SPINE BORDEAUX XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM IMPLANT Back to Search Results
Catalog Number 482317540
Event Date 10/18/2012
Event Type  Malfunction  
Event Description

It was reported, "during final tightening tulip head became disengaged from screw shaft on a 7. 5 x 40 screw placed in the sacrum on a l4-s1 construct. Dr (b)(6) noted that there was a really good bite on the screw and that it was seated in a way that the rod did not sit in the bottom of the screw. The final tightening devices were placed onto the screw/blocker/rod to tighten and it did not feel right. Dr (b)(6) took the construct apart to check the screw and the tulip pulled right off. Dr (b)(6) did comment that his suspicion is that because of the strength of the screws purchase that it would not move upward so the joint, being the weakest part failed.

 
Manufacturer Narrative

Additional info has been requested and if made available will be reported in a supplemental. Method, result, and conclusion codes will be made available following an engineering eval.

 
Search Alerts/Recalls
Source: FDA