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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 6.5X55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 6.5X55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482802655
Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Date 07/29/2019
Event Type  Injury  
Event Description
It was reported that patient presented with pain, x-ray confirmed the breakage of an es2 integrated screw at l3 right.During revision surgery on (b)(6) 2019, the proximal end of the broken screw was removed, however, the distal end of the screw could not be explanted and remains in the vertebra l3 level.A new screw was implanted and the construct was extended by one level.
 
Manufacturer Narrative
Visual inspection confirmed fractured screw at threading/main body.Fractured tip was not returned as it remains implanted in the patient.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.No complication during initial surgery was reported, patient did not experience any fall/ trauma.Patient is 66 years old male, weighs 110kg with height 190cm.From es2 augmentable ifu: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.An overweight or obese patient can produce loads on the spine which can lead to failure of the fixation of the device or to failure of the device itself.Based on available information, root cause of reported event is most likely excess load placed on construct due to patient obesity.
 
Event Description
It was reported that patient presented with pain, x-ray confirmed the breakage of an es2 integrated screw at l3 right.During revision surgery on (b)(6) 2019, the proximal end of the broken screw was removed, however, the distal end of the screw could not be explanted and remains in the vertebra l3 level.A new screw was implanted and the construct was extended by one level.
 
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Brand Name
ES2 INTEGRATED BLADE SCREW SIZE S 6.5X55MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8977793
MDR Text Key157063647
Report Number0009617544-2019-00109
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327001969
UDI-Public07613327001969
Combination Product (y/n)N
PMA/PMN Number
K122845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number482802655
Device Lot Number173648
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight110
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