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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48232600
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 04/26/2018
Event Type  Injury  
Event Description
It was reported that the patient was implanted from t8 to iliac and fixed from t10 to l3/4 with 4 rods on (b)(6) 2014.On (b)(6) 2018 it was confirmed both side rods were broken.Right broken part was l5/s and left broken part was secru / iliac.On (b)(6) 2018 rods were removed and revised.
 
Manufacturer Narrative
Method: visual analysis, material analysis, device history review, complaint history review, risk assessment.Result: the rod was returned in 2 pieces with the hex end fractured from the rest of the rod.The device was sent for material analysis.The elemental constituent was consistent with the material listed on the print.Material analysis of the device confirmed fatigue fracture at the contact point with the polyaxial screw.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely root cause is fatigue fracture of the rod due to length of implantation.As non fusion, patient activity level, and patient fall are unknown, these can also be contributing factors to the rod fracture.
 
Event Description
It was reported that the patient was implanted from t8 to iliac and fixed from t10 to l3/4 with 4 rods on (b)(6) 2014.On (b)(6) 2018 it was confirmed both side rods were broken.Right broken part was l5/s and left broken part was secru / iliac.On (b)(6) 2018 rods were removed and revised.
 
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Brand Name
XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7537704
MDR Text Key109042022
Report Number0009617544-2018-00110
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48232600
Device Lot NumberGC6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Date Manufacturer Received07/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight57
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