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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 48824016
Device Problems Device Slipped (1584); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  malfunction  
Event Description
It was reported that the patient was scheduled for 1 level acdf revision procedure due to degenerative disc disease.Right before the procedure, x-ray review revealed that screw from plate was backing out from previous surgery.Therefore, the surgeon replaced the plate and screws during revision surgery and this resulted in 30 minutes surgical delay.
 
Manufacturer Narrative
Visual inspection: the screws were inspected and no issues where observed.Functional inspection: could not performed because the device was confirmed to be damaged during visual inspection.Dimensional inspection not performed because there is no indication the event was related to dimensions of the device.Material analysis was not performed as there is no indication the event was related to the material properties of the device.Complaint history review for similar events and device history records were reviewed and no relevant manufacturing issues nor similar events were identified.It was confirmed via visual inspection that the screw backing out of the plate caused the spring deformation.There were no complications with the original surgery.The patient¿s bone quality and post-operative activity are unknown.It is not known if the patient fused.The potential root causes include:- poor surgical candidate or bone quality.Excessive post-op activity by patient (not recommended by surgeon).Patient does not follow surgeon instructions.Patient over exerts.
 
Event Description
It was reported that the patient was scheduled for 1 level acdf revision procedure due to degenerative disc disease.Right before the procedure, x-ray review revealed that screw from plate was backing out from previous surgery.Therefore, the surgeon replaced the plate and screws during revision surgery and this resulted in 30 minutes surgical delay.
 
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Brand Name
AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8518411
MDR Text Key142395900
Report Number0009617544-2019-00049
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier07613252152613
UDI-Public07613252152613
Combination Product (y/n)N
PMA/PMN Number
K142237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48824016
Device Lot NumberXRZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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