MONDIAL 6 (DEVICE 1) A1 / L362 66016863

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-09-26 for MONDIAL 6 (DEVICE 1) A1 / L362 66016863 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[3780533] This is the first of two reports on two separate devices for one incident. (b)(6) 2013 - the dentist called because he had a very upset patient that had just received her implant retained bridge one month ago and three of the teeth broke. He said that teeth 21, 22, and 23 broke. He has the pieces and needs immediate replacement. He said that the pt is upset but otherwise fine. (b)(6) 2013 - spoke to lab technician. He said that he has made many all on 4 implants and dentures using mondial and never had this before. He said that this was the full mouth fixed all on 4 style implant. He said it is probably the pt's inability to feel that caused the breakage issue. Mfr ref # 3006610834-2013-00015.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2013-00140
MDR Report Key3451501
Report Source99
Date Received2013-09-26
Date of Report2013-08-30
Date Facility Aware2013-08-30
Date Added to Maude2013-11-07
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONDIAL 6 (DEVICE 1)
Generic NameELM DENTURE, PLASTIC, TEETH
Product CodeELM
Date Received2013-09-26
Returned To Mfg2013-09-09
Model NumberA1 / L362
Catalog Number66016863
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressWASSERBURG 88142 GM 88142


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-26

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