HEAL COLLAR 3.5X4.5, 3MM HC343

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 2020-03-03 for HEAL COLLAR 3.5X4.5, 3MM HC343 manufactured by Zimmer Dental.

Event Text Entries

[181997901] Zimmer biomet complaint (b)(4). Patient weight not provided/unknown.
Patient Sequence No: 1, Text Type: N, H10


[181997902] It was reported that during the placement procedure, the healing abutment became stuck in the implant and would not disengage. The implant was removed and another one was placed during the same procedure. Tooth location 8.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00475
MDR Report Key9781869
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-01-30
Date Mfgr Received2020-02-11
Device Manufacturer Date2018-01-09
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 3.5X4.5, 3MM
Generic NameHEALING COLLAR
Product CodeNHA
Date Received2020-03-03
Returned To Mfg2020-02-18
Catalog NumberHC343
Lot Number2018010400
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 2020-03-03

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