FDA.reportPublic FDA data

MAUDE MDR 6534906

MDR report key
6534906
Report number
1045254-2017-00133
Event key
0
Event type
3
Date received
2017-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHELLE ALFORD
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROSTHESISREPLACEMENT, OSSICULAR PROSTHESIS, TOTALMEDTRONIC XOMED, INCETAXOM UNK PROSTHESISXOM UNK PROSTHESISN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-0101. O

Event Narratives#

N

Patient 1

PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

A REVIEW OF THE JOURNAL ARTICLE ?VASCULARIZATION OF THE LONG PROCESS OF THE MALLEUS: SURGICAL IMPLICATIONS?, VALLEJO-VALDEZATE, ET AL; EUR ARCH OTORHINOLARYNGOL (2016) 273:2335?2342. "THE DETACHMENT OF THE TYMPANIC MEMBRANE TO FASTEN A MVP PROSTHESIS CAUSES A DAMAGE IN THE PERIOSTEAL/PERICHONDRAL VASCULAR SUPPLY OF THE HANDLE AS WELL AS MICRO-TRAUMA ON IT, WHICH CAN PROMOTE BONE RESORPTION AT THE POINT OF ANCHORAGE BY OSTEOCLAST STIMULATION. RESPECT PERIOSTEA VASCULARIZATION OF THE MANUBRIUM MAY BE IMPORTANT TO PREVENT DAMAGE IN THIS OSSICLE CAUSED BY SOME MIDDLE EAR RECONSTRUCTION PROSTHESES.? ?DATA FROM PATIENTS WHO UNDERWENT A MALLEOVESTIBULOPEXY DURING A 3-YEAR PERIOD WERE COLLECTED. IN THOSE CASES, ATTENTION WAS FOCUSED ON THE PERMANENCE OF THE PROSTHESES AND THEIR POSITION, THE PRESENCE OF EROSION IN THE LONG PROCESS OF THE MALLEUS AND THE ENTOTYMPANIC PRESSURE.? RESULTS REPORT THAT ?IN 3 OF THE CASES, THE PROSTHESIS EXTRUDED SPONTANEOUSLY LEAVING SOME KIND OF DAMAGE [EROSION OR COMPLETE FRACTURE] OF THE LONG PROCESS OF THE MALLEUS.? THIS FILE WILL INVESTIGATE A PATIENT WHO UNDERWENT "CHOLESTEATOMA PRIMARY SURGERY." FOLLOW UP WITH THE PATIENT OCCURRED 13 MONTHS POST OPERATIVELY. IT WAS FOUND THAT THERE WAS AN "ABSENCE OF PROSTHESIS, EROSION OF THE SUPERIOR THIRD OF THE HANDLE AND A DEHISCENT JUGULAR GULF."

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.