MONDIAL 6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-08-13 for MONDIAL 6 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[17158512] (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[17503080] As allowed by (b)(4), (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Conclusion code: weakening of artificial teeth through excessive trimming out of teeth especially in retention areas in the framework and the drilling of retention holes in teeth. Improper fitting of device due to implant pts often lack of feeling for their occlusal load. We are closely working with the labs that have experienced this issue as most labs do not have any breakage issues. The current complaint rate for mondial teeth is less than 0. 05%.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006610834-2013-00007
MDR Report Key3300005
Report Source00,07
Date Received2013-08-13
Date Mfgr Received2013-06-06
Date Added to Maude2013-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactAUDI BOGUCKI, RDH
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 466140000
Manufacturer CountryUS
Manufacturer Postal466140000
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetSCHLATTEREST 2
Manufacturer CityWASSERBURG 88142
Manufacturer CountryGM
Manufacturer Postal Code88142
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONDIAL 6
Product CodeELM
Date Received2013-08-13
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressWASSERBURG 88142 GM 88142


Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-13

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