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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTIMPLANT ARTELON CMC SPACER

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ARTIMPLANT ARTELON CMC SPACER Back to Search Results
Model Number 21109
Device Problem Explanted
Event Date 08/18/2008
Event Type  Injury  
Event Description

An artelon spacer explanted due to pain.

 
Manufacturer Narrative

Evaluation of lot documentation. Code: lot documentation was ok. Problems with the fixation of the spacers in spite of experienced surgeon.

 
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Brand NameARTELON CMC SPACER
Type of DeviceSPACER
Manufacturer (Section D)
ARTIMPLANT
vastra frolunda
SW 
Manufacturer Contact
hulda mellgrens gata 5
vastra frolunda  SE-42-1 32
17465600
MDR Report Key1394016
Report Number3004878714-2009-00014
Device Sequence Number1
Product CodeKYI
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/11/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2011
Device MODEL Number21109
Device LOT Number0603001876
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/03/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/11/2009 Patient Sequence Number: 1
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