MONDIAL 6 BL2 R455 66801027

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-13 for MONDIAL 6 BL2 R455 66801027 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[3608535] This is the eighth of thirteen device reports from one dental lab. A dental lab notified local hk rep of mondial teeth they want to replace due to shearing. The lab did not give individual info on pts and dates. The hk rep explained that this happens with the all-on 4's and the fact that the teeth shear before the implant does is a good thing. On (b)(6) 2013, contacted the denture set up guys from the lab. They said the teeth sheared while in the pt's mouth. They said the pt would bite down on something and shear a tooth at the gum line. They would drill the rest of the tooth out and replace the tooth. There was no incident of a pt being injured from this, no aspiration or ingestion. On (b)(6) 2013, sent a list of questions for the lab concerning the shearing of teeth. The lab declined to respond to these questions. The lab no longer has the teeth therefore they will not be returning them for eval. This incident involved denture tooth #7. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2013-00106
MDR Report Key3300117
Date Received2013-08-13
Date of Report2013-06-06
Date Facility Aware2013-06-06
Date Added to Maude2013-08-22
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 466142517
Manufacturer CountryUS
Manufacturer Postal466142517
Manufacturer G1HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 46614251
Manufacturer CountryUS
Manufacturer Postal Code46614 2517
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMONDIAL 6
Product CodeELM
Date Received2013-08-13
Model NumberBL2 R455
Catalog Number66801027
OperatorOTHER
Device AvailabilityN
Device AgeDA
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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