N/A UNKNOWN ELEVATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for N/A UNKNOWN ELEVATOR manufactured by Biomet Microfixation.

Event Text Entries

[142335812] (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[142335813] It was reported that the elevator tip fractured during a procedure. The customer at the facility was able to confirm that there was no patient injury or surgical delay in excess of 30 minutes related to the fracture. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2019-00228
MDR Report Key8520388
Date Received2019-04-16
Date of Report2019-07-17
Date Mfgr Received2019-07-17
Date Added to Maude2019-04-16
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 Report0

Device Details

Generic NameELEVATOR, SURGICAL, DENTAL
Product CodeEMJ
Date Received2019-04-16
Model NumberN/A
Catalog NumberUNKNOWN ELEVATOR
Lot NumberUNK
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 2019-04-16

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