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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS 5.5 X 600MM SPINAL ROD WITH HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US RADIUS 5.5 X 600MM SPINAL ROD WITH HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 486613600
Device Problems Device Dislodged or Dislocated (2923); Migration (4003)
Patient Problems Injury (2348); No Information (3190)
Event Date 12/15/2018
Event Type  Injury  
Event Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.
 
Manufacturer Narrative
Catalog # updated to 486613600.Gtin # added.510(k)# added.
 
Event Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.
 
Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via x-ray by doctor and correspondence.No lot # was provided and cage was discarded, so a manufacturing record review could not be performed.Conclusion: the root cause of the reported event is likely due to lack of enough tightness during supplemental fixation system installation.
 
Event Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.
 
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Brand Name
RADIUS 5.5 X 600MM SPINAL ROD WITH HEX
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8244442
MDR Text Key132950850
Report Number0009617544-2019-00005
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,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number486613600
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
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