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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS AVALIGN MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10")

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AVALIGN GERMAN SPECIALTY INSTRUMENTS AVALIGN MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10") Back to Search Results
Catalog Number L-0130
Device Problems Break (1069); Fracture (1260)
Patient Problem Missing Value Reason (3192)
Event Date 03/22/2019
Event Type  malfunction  
Manufacturer Narrative
Device was manufactured december 2006, sold to reporting facility network under 2 invoices: january 2007 and march 2007. Per k081651, devices are provided non-sterile and reusable. The devices are shown to withstand a minimum of 20 cycles when sterilized according to the instructions.
 
Event Description
Front portion of device broke off into patient's brain tissue while in use. The broken portion of the instrument was retrieved and the instrument was removed from service.
 
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Brand NameAVALIGN
Type of DeviceMICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10")
Manufacturer (Section D)
AVALIGN GERMAN SPECIALTY INSTRUMENTS
626 cooper ct
schaumburg IL 60173
Manufacturer (Section G)
AVALIGN GERMAN SPECIALTY INSTRUMENTS
626 cooper ct
schaumburg IL 60173
Manufacturer Contact
jennifer staunton
626 cooper ct
schaumburg, IL 60173
8479080292
MDR Report Key8705999
MDR Text Key179225607
Report Number1421101-2019-00001
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberL-0130
Device Lot Number120406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/17/2019 Patient Sequence Number: 1
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