MAUDE MDR 2863078

MDR report key
2863078
Report number
1045254-2012-00699
Event key
0
Event type
3
Date received
2012-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JACKLYN HAYMAN
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9042
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROSTHESIS 1112065 H/A PARTIAL 90DEG RECPROSTHESIS, PARTIAL OSSICULAR REPLACEMENTXOMED MFG JACKSONVILLEETA11120651112065NOT PROVIDED* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-1001. R

Event Narratives#

D

Patient 1

A LITERATURE REVIEW WAS PERFORMED ON AN ARTICLE PUBLISHED IN THE JOURNAL "OTOLOGY & NEUROTOLOGY" IN 2010 ENTITLED, "TITANIUM VERSUS NONTITANIUM OSSICULAR PROSTHESES - A RANDOMIZED CONTROLLED STUDY OF THE MEDIUM-TERM OUTCOME," BY MATTHEW YUNG AND PHILIP SMITH. THE ARTICLE DISCUSSED A STUDY COMPARING THE MEDIUM-TERM OUTCOME OF OSSICULOPLASTY USING TITANIUM (TI) AND NON-TI PROSTHESES. THE STUDY WAS CONDUCTED BETWEEN 2002 AND 2007 ON PATIENTS WHO REQUIRED OSSICULAR RECONSTRUCTIONS AND HAD CASES OF CHRONIC OTITIS MEDIA. THE PATIENT DEMOGRAPHICS INCLUDED BOTH MALES AND FEMALES RANGING FROM 10 TO 78 YEARS IN AGE, 8 OF WHICH WERE 16 YEARS OF AGE OR YOUNGER. OF 94 OSSICULOPLASTIES RECRUITED, 45 WERE HA PROSTHESIS AND FROM THIS 19 WERE HA TORP AND 26 WERE HA PORP. MEDTRONIC PRODUCTS WERE USED IN ONLY THE NON-TI CASES WHERE THE FOLLOWING ISSUES REPORTED: 1.) PROSTHESIS EXTRUSION OR EXPOSURE OF HEAD PLATE VERSUS NON-EXTRUSION (2 CASES) 2.) CARTILAGE PLATES PLACED OVER THE HEAD PLATE OF THE HA PROSTHESES IN CASES OF ATELECTASIS. (CASES NOT SPECIFIED) POINTS REPORTED IN THE ARTICLE: 1.) NO SIGNIFICANT DIFFERENCE BETWEEN TI (NON-MEDTRONIC PRODUCT) AND NON-TI (MEDTRONIC PRODUCT)FOR BOTH PORPS AND TORPS. 2.) NO SIGNIFICANT DIFFERENCE IN THE EXTRUSION RATE BETWEEN BOTH PROSTHESES. 3.) RESULT OF STUDY IS CONSISTENT WITH THOSE OF A PREVIOUS LONG-TERM STUDY ON OSSICULOPLASTY OUTCOMES SHOWING INFLUENCE BY MIDDLE EAR PATHOLOGIES RATHER THAN SURGICAL TECHNIQUES.

N

Patient 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THIS IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNING. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: ACTUAL DEVICE NOT EVALUATED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE NOT RETURNED.