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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 54; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 54; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Catalog Number 48811354
Device Problems Bent (1059); Break (1069); Fracture (1260); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2016
Event Type  malfunction  
Event Description
It was reported that the screws were inserted and engarded with late at all levels without incident.Upon final cam lock tightening it was noticed by the surgeon that the spring bar had deform unilaterally at two separate levels.Sling bar did not translate and was bent / pinched under the screw lip.This made the plate unable to lock at all levels.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no anomalies were found.It appears that the surgical technique was followed.Conclusion: the probable root cause is not determined.
 
Event Description
It was reported that the screws were inserted and engarded with late at all levels without incident.Upon final cam lock tightening it was noticed by the surgeon that the spring bar had deform unilaterally at two separate levels.Sling bar did not translate and was bent / pinched under the screw lip.This made the plate unable to lock at all levels.
 
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Brand Name
AVIATOR ASSY THREE LEVEL PLATE SIZE 54
Type of Device
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5514728
MDR Text Key40843492
Report Number0009617544-2016-00125
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier07613252152316
UDI-Public(01)07613252152316
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48811354
Device Lot Number14J093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2016
Initial Date FDA Received03/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/10/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
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