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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRACE MEDICAL, INC. DORNHOFFER ALTO PARTIAL; PARTIAL OSSICULAR REPLACEMENT PROSTH
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GRACE MEDICAL, INC. DORNHOFFER ALTO PARTIAL; PARTIAL OSSICULAR REPLACEMENT PROSTH Back to Search Results
Catalog Number 695
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Patient received a partial ossicular prosthesis.Patient initially had perfect hearing results.Patient suddenly developed max conductive hearing loss.An exam had shown the prosthesis in position but too short and deep to malleus.
 
Manufacturer Narrative
The patient is to be scheduled for a revision surgery at some point in the future.When additional information is received and/or the prosthesis is returned, a follow-up report will be submitted.
 
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Brand Name
DORNHOFFER ALTO PARTIAL
Type of Device
PARTIAL OSSICULAR REPLACEMENT PROSTH
Manufacturer (Section D)
GRACE MEDICAL, INC.
memphis TN
Manufacturer Contact
bill graham
8500 wolf lake dr., ste. 110
memphis, TN 38133
9073860990
MDR Report Key3964885
MDR Text Key21243424
Report Number1057421-2014-00001
Device Sequence Number1
Product Code ETA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
061853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 06/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2015
Device Catalogue Number695
Device Lot Number21829
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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