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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ILIOS TITANIUM SMALL R-R CONNECTOR 0 DEG; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US ILIOS TITANIUM SMALL R-R CONNECTOR 0 DEG; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 03820134
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
Event Type  Injury  
Event Description
It was reported that a patient underwent revision surgery to address a migrated set screw in a xia ii rod-to-rod connector.
 
Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
 
Event Description
It was reported that a patient underwent revision surgery to address a migrated set screw in a xia ii rod-to-rod connector.
 
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Brand Name
ILIOS TITANIUM SMALL R-R CONNECTOR 0 DEG
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key18088081
MDR Text Key327566447
Report Number0009617544-2023-00070
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060361
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 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03820134
Device Lot Number220909
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2022
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 Outcome(s) Required Intervention;
Patient SexFemale
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