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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 30; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 30; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Model Number 48811230
Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2017
Event Type  malfunction  
Event Description
It was reported that after the surgeon performed a two level acdf on a patient he happen to touch the plate prior to closing the incision and realized there was something sharp protruding.He then noticed that the locking spring ring had popped out.
 
Manufacturer Narrative
Manufacturing files were reviewed and no anomalies were found.The plate was confirmed visually to have a deformed spring bar.The plausible root cause is undetermined.
 
Event Description
It was reported that after the surgeon performed a two level acdf on a patient he happen to touch the plate prior to closing the incision and realized there was something sharp protruding.He then noticed that the locking spring ring had popped out.
 
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Brand Name
AVIATOR ASSY TWO LEVEL PLATE SIZE 30
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 Key6720066
MDR Text Key80414216
Report Number0009617544-2017-00287
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier07613252152194
UDI-Public(01)07613252152194
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48811230
Device Catalogue Number48811230
Device Lot Number166630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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