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 health professional report with the FDA on 2020-03-26 for CERTAIN? GOLD-TITE? HEXED SCREW IUNIHG manufactured by Biomet 3i.

Event Text Entries

[185104625] Zimmer biomet (b)(4). Weight unknown / not provided. Date of event unknown / not provided. Lot number unknown / not provided. Unknown / not provided. Unknown / not provided. Device manufacturer date unknown / not provided.
Patient Sequence No: 1, Text Type: N, H10


[185104626] It was reported that the screw at implant site #31 fractured in a well seated biomet t3 5. 0 implant. Removal tools purchased and is requesting replacement screw. Patient to return for screw removal. As a result of this event, no injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001038806-2020-00575
MDR Report Key9883911
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-26
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 Received2020-03-26
Returned To Mfg2020-03-16
Catalog NumberIUNIHG
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOMET 3I
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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