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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS TL SPACER 12 X 30 X 4 DEG; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE AVS TL SPACER 12 X 30 X 4 DEG; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Back to Search Results
Catalog Number 48370124
Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2014
Event Type  malfunction  
Event Description
It was reported that avs tl cage insertion hole became deformed during impaction.The collet inserter could no longer hold onto the implant.We used a second cage and completed the case without any further issues.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the manufacturing records were reviewed and no anomalies were found.Conclusion: the probable root cause is not determined due to lack of availability of the device, it was reportedly returned, however not able to be located onsite.
 
Event Description
It was reported that avs tl cage insertion hole became deformed during impaction.The collet inserter could no longer hold onto the implant.We used a second cage and completed the case without any further issues.
 
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Brand Name
AVS TL SPACER 12 X 30 X 4 DEG
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 Key4357878
MDR Text Key20123283
Report Number0009617544-2014-00534
Device Sequence Number1
Product Code MQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48370124
Device Lot Number45167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/03/2007
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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