MODIFIED BECK ELEVATOR N/A SP-2359

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-01 for MODIFIED BECK ELEVATOR N/A SP-2359 manufactured by Biomet Microfixation.

Event Text Entries

[140535406] Zimmer biomet complaint (b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00193.
Patient Sequence No: 1, Text Type: N, H10


[140535407] It was reported that two elevators fractured at the tip. Attempts have been made and no further information has been provided. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2019-00194
MDR Report Key8470567
Report SourceDISTRIBUTOR
Date Received2019-04-01
Date of Report2019-06-04
Date Mfgr Received2019-05-21
Device Manufacturer Date2017-10-19
Date Added to Maude2019-04-01
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 ContactMR. ALAN MUNOZ
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9043677142
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 NameMODIFIED BECK ELEVATOR
Generic NameELEVATOR, SURGICAL, DENTAL
Product CodeEMJ
Date Received2019-04-01
Returned To Mfg2019-04-01
Model NumberN/A
Catalog NumberSP-2359
Lot Number091917I17
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 2019-04-01

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