ELEVATOR #77R N/A 09-0313

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-15 for ELEVATOR #77R N/A 09-0313 manufactured by Biomet Microfixation.

Event Text Entries

[136291411] (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


[136291412] It was reported the tip of the elevator fractured during use. The fractured piece was removed via suction. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2019-00122
MDR Report Key8344061
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-02-15
Date of Report2019-05-29
Date Mfgr Received2019-04-29
Device Manufacturer Date2018-05-11
Date Added to Maude2019-02-15
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. MICHELLE COLE
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
Event Type3
Type of Report3

Device Details

Brand NameELEVATOR #77R
Generic NameELEVATOR, SURGICAL, DENTAL
Product CodeEMJ
Date Received2019-02-15
Returned To Mfg2019-04-22
Model NumberN/A
Catalog Number09-0313
Lot Number042518D18
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-15

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