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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 Implant, removal of
Event Date 01/19/2009
Event Type  Injury  
Event Description

A standard artelon spacer was implanted in 2007 and revised in 2009 by addressing "bone carpentry" issues that remained following the original surgery and by implanting an artelon lg spacer. The revision surgery was performed to address the pt's complaints of pain and swelling in the cmc joint.

 
Manufacturer Narrative

No product available, investigation based on info from distributor only. Artelon spacer "tightly adherent to both the trapezium and the thumb metacarpal" which indicates that the metacarpal joint surface was injured during the initial surgery. See scanned page.

 
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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 Key1412436
Report Number3004878714-2009-00021
Device Sequence Number1
Product CodeKYI
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number21109
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/09/2009
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/30/2009 Patient Sequence Number: 1
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