EXODONTIA ELEVATOR #46R, SERRATED N/A 09-0252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-24 for EXODONTIA ELEVATOR #46R, SERRATED N/A 09-0252 manufactured by Biomet Microfixation.

Event Text Entries

[146105425] (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[146105426] It was reported that the tip of the instrument fractured during a tooth extraction. The tip was removed from the patient's mouth via suction and the procedure was completed with another instrument.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2019-00299
MDR Report Key8641689
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-24
Date of Report2019-07-30
Date Mfgr Received2019-07-30
Device Manufacturer Date2016-11-08
Date Added to Maude2019-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 FDA3
Event Location3
Manufacturer ContactMRS. MERRIANNE CASSIDY
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameEXODONTIA ELEVATOR #46R, SERRATED
Generic NameELEVATOR, SURGICAL, DENTAL
Product CodeEMJ
Date Received2019-05-24
Model NumberN/A
Catalog Number09-0252
Lot Number110416J16
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-24

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