HEAL COLLAR 4.5X4.5, 5MM HC445

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for HEAL COLLAR 4.5X4.5, 5MM HC445 manufactured by Zimmer Dental.

Event Text Entries

[185907731] 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. Implant date unknown / not provided. Explant date unknown / not provided. Device manufacturer date number unknown / not provided.
Patient Sequence No: 1, Text Type: N, H10


[185907732] It was reported that the healing abutment would not seat on the implant. They were able to complete the procedure with another same size healing abutment. Tooth location unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002023141-2020-00651
MDR Report Key9886127
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-04
Date Mfgr Received2020-03-05
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 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 4.5X4.5, 5MM
Generic NameHEALING COLLAR
Product CodeNHA
Date Received2020-03-26
Returned To Mfg2020-03-11
Model NumberHC445
Catalog NumberHC445
Lot Number2018011539
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
101. Required No Informationntervention 2020-03-26

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