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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 28MM 31MM; IMPLANT-CONNECTOR
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STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 28MM 31MM; IMPLANT-CONNECTOR Back to Search Results
Catalog Number 48236028
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 09/10/2014
Event Type  malfunction  
Event Description
It was reported that revision surgery performed to repair a pseudoarthrosis and used a side by side connector.Patient brought in for surgery because x-ray showed the rod was not engaged in tulip head of connector.The dr.Decided to replace the entire rod from t4-pelvis.Upon exposure also notice the mac connector had broken (originally implanted a year ago).
 
Manufacturer Narrative
Method: device history review and device evaluation.Results: no manufacturing issues were identified.Visual inspection noted the returned cross connector was confirmed to be fractured at the neck closest to one of the hooks.The connector had multiple scratches and indentations present.The set screw was received unthreaded from the hook.Material analysis noted the multi-axial crosslink was found to have fractured in fatigue.Heavy damage on the surface prevented the determination of the origin and progression.The material was found to conform to the material listed on the print.No material or manufacturing defects were found.Conclusion: it was determined that the device broke through fatigue and that no material or manufacturing defects were found.The most likely cause of the customer reported event is fatigue of the device with the length of implantation contributing to the event.
 
Event Description
It was reported that revision surgery performed to repair a pseudoarthrosis and used a side by side connector.Patient brought in for surgery because x-ray showed the rod was not engaged in tulip head of connector.The dr.Decided to replace the entire rod from t4-pelvis.Upon exposure also notice the mac connector had broken (originally implanted a year ago).
 
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Brand Name
XIA 3 TITANIUM MULTIAXIAL CROSSLINK 28MM 31MM
Type of Device
IMPLANT-CONNECTOR
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4154880
MDR Text Key4914148
Report Number0009617544-2014-00434
Device Sequence Number1
Product Code OSH
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 09/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48236028
Device Lot Number080663
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2008
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 Age70 YR
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