HEAL COLLAR 3.5X3.5, 5MM HC335

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 2020-03-09 for HEAL COLLAR 3.5X3.5, 5MM HC335 manufactured by Zimmer Dental.

Event Text Entries

[182599534] Zimmer biomet complaint number (b)(4). Patient identifier unknown / not provided. Age and date of birth unknown / not provided. Patient sex unknown / not provided. Weight unknown / not provided.
Patient Sequence No: 1, Text Type: N, H10


[182599535] It was reported that the healing collar would not screw into the implant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00513
MDR Report Key9806560
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-02-18
Date Added to Maude2020-03-09
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 NameHEAL COLLAR 3.5X3.5, 5MM
Generic NameHEALING COLLAR
Product CodeNHA
Date Received2020-03-09
Returned To Mfg2020-02-18
Catalog NumberHC335
Lot Number2019021116
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 2020-03-09

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