RETAINING 2.5MM HEX DRIVE R LONG RHL2.5

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 2020-01-16 for RETAINING 2.5MM HEX DRIVE R LONG RHL2.5 manufactured by Zimmer Dental.

Event Text Entries

[175427759] Zimmer biomet complaint (b)(4). Patient id and weight not provided/unknown. Device lot number not provided/unknown. Reporter's first name not provided/unknown. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[175427760] It was reported that the hex tool and the implant would not disengage. The implant had to be removed and the procedure was completed with another implant and tool. Tooth location 19.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00108
MDR Report Key9597743
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-16
Date of Report2020-03-30
Date of Event2019-12-17
Date Mfgr Received2020-03-18
Date Added to Maude2020-01-16
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 ContactMS SUSANNE TAYLOR
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1ZIMMER DENTAL
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 NameRETAINING 2.5MM HEX DRIVE R LONG
Generic NameDRIVER
Product CodeNDP
Date Received2020-01-16
Catalog NumberRHL2.5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER DENTAL
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

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