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Adverse Event Report

ACUMED   back to search results
Catalog Number HD0015
Event Date 09/13/2002
Event Type  Other  
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Baseline Brand NameMINI-ACUTRAK
Baseline Generic NameORTHOPEDIC INSTRUMENT
Baseline Catalogue NumberHD0015
Other Baseline ID NumberATM-080 (HANDLE)
Baseline Device FamilyACUTRAK SOLID HEX DRIVERS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)NA
Date First Marketed05/05/1995
Manufacturer (Section F)
ACUMED
5885 nw cornelius pass road
hillsboro OR 97124
Manufacturer (Section D)
ACUMED
5885 nw cornelius pass road
hillsboro OR 97124
Manufacturer Contact
sue richardson
5885 nw cornelius pass road
hillsboro , OR 97124
(503) 627 -9957
Device Event Key408104
MDR Report Key430207
Event Key396324
Report Number3025141-2002-00012
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type User facility
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2002
Device Catalogue NumberHD0015
Device LOT Number041796AA
Date Manufacturer Received11/15/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Unkown

Database last updated on January 30, 2009

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