TOOL HEX 3MM HEX-HOLE SQ CONN 28MM SST HXL3.0-S

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 2020-02-28 for TOOL HEX 3MM HEX-HOLE SQ CONN 28MM SST HXL3.0-S manufactured by Zimmer Dental.

Event Text Entries

[182190915] Zimmer biomet complaint (b)(4). Patient identifier is not provided / unknown. Patient age is not provided / unknown. Patient weight is not provided / unknown. Date of event is not provided / unknown.
Patient Sequence No: 1, Text Type: N, H10


[182190916] Doctor reported that the hxl3. 0-s tool will not hold the implant. The implant falls right off once tool flipped upside down for placement. Doctor reports the implant was placed, no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00436
MDR Report Key9770167
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-28
Date of Report2020-02-28
Date Mfgr Received2020-02-06
Date Added to Maude2020-02-28
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 NameTOOL HEX 3MM HEX-HOLE SQ CONN 28MM SST
Generic NameDENTAL TOOL
Product CodeNDP
Date Received2020-02-28
Returned To Mfg2020-02-26
Catalog NumberHXL3.0-S
Lot Number63430686
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerZIMMER DENTAL
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.