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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 48844016
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)
Date of Event 03/12/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to screw pull out post-operatively.
 
Additional Manufacturer Narrative
This device is confirmed to be a concomitant product.No issue with this screw was reported by the sales representative.
 
Event or Problem Description
The device has been deemed concomitant.
 
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Brand Name
AVIATOR FIXED SELF DRILLING SCREW 4X16MM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8501421
Report Number0009617544-2019-00044
Device Sequence Number16479195
Product Code KWQ
UDI-Device Identifier07613252254713
UDI-Public07613252254713
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K142237
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/24/2019
1 Device was Involved in the Event
2 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number48844016
Device Lot Number269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Initial Date Received by Manufacturer 03/12/2019
Supplement Date Received by Manufacturer05/30/2019
Initial Report FDA Received Date04/10/2019
Supplement Report FDA Received Date06/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Patient Age57 YR
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