FDA.reportPublic FDA data

MAUDE MDR 8132136

MDR report key
8132136
Report number
9710014-2018-00976
Event key
0
Event type
3
Date received
2018-12-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAURA SIMONOTTI
Address
FUERSTENWEG 77A INNSBRUCK 6020 AU
Phone
577-577-5778
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BONEBRIDGEBCI BONE CONDUCTION IMPLANTMED-EL ELEKTROMEDIZINISCHE GERAETE GMBHPFOBCI BONE CONDUCTION IMPLANTN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-050

Event Narratives#

N

Patient 1

BASED ON THE CURRENTLY AVAILABLE INFORMATION, A MECHANICAL DAMAGE TO THE IMPLANT DUE TO THE REPORTED EXTERNAL IMPACT APPEARS LIKELY. HOWEVER, TO DETERMINE AND CONFIRM AN EXACT ROOT CAUSE OF FAILURE A DEVICE INVESTIGATION AT THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION IS SCHEDULED FOR (B)(6) 2019. THIS IS A COMBINED INITIAL AND FINAL REPORT.

D

Patient 1

ACCORDING TO THE SURGEON THE DEVICE WAS DAMAGED FOLLOWING A TRAUMA. PRIOR TO THIS EVENT THE DEVICE WAS BEING USED WITHOUT ANY PROBLEMS. RE-IMPLANTATION IS SCHEDULED FOR (B)(6) 2019, AND THERE IS NO PLANNED APPOINTMENT BEFORE THIS DATE.