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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS, LLC KERRISON PUNCH, SURGICAL

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AESCULAP IMPLANT SYSTEMS, LLC KERRISON PUNCH, SURGICAL Back to Search Results
Model Number 7 IN 1MM
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2016
Event Type  malfunction  
Event Description
The tip of a kerrison broke off in patient during use. The surgeon was able to remove the tip with the use of the microscope.
 
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Brand NameKERRISON
Type of DevicePUNCH, SURGICAL
Manufacturer (Section D)
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley PA 18034
MDR Report Key5825343
MDR Text Key50528769
Report Number5825343
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/13/2016,07/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7 IN 1MM
Device Catalogue NumberFF771R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2016
Event Location Hospital
Date Report to Manufacturer07/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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