CERTAIN? GOLD-TITE? HEXED SCREW IUNIHG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for CERTAIN? GOLD-TITE? HEXED SCREW IUNIHG manufactured by Biomet 3i.

Event Text Entries

[182134519] Zimmer biomet (b)(4). Age: not provided. Initial reporter fax number: not provided. Device was not returned
Patient Sequence No: 1, Text Type: N, H10


[182134520] It was reported that abutment screw (iunihg) fractured within the implant during crown loading at tooth location 19. All fractured parts were removed and implant remains intact. Another abutment was placed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001038806-2020-00466
MDR Report Key9788240
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-04
Date of Report2020-03-04
Date of Event2019-12-17
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-04
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 ContactMS SUSANNE TAYLOR
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1BIOMET 3I
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERTAIN? GOLD-TITE? HEXED SCREW
Generic NameDENTAL SCREW
Product CodeNHA
Date Received2020-03-04
Catalog NumberIUNIHG
Lot Number1186478
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET 3I
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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