LEGACY HEALING COLLAR 8530-15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for LEGACY HEALING COLLAR 8530-15 manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[186203436] Information was not provided and if it becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186203437] Per (b)(4), patient experienced loss or failure of implant to integrate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2020-03176
MDR Report Key9902355
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-08-19
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMRS ADRIENNE STOTT
Manufacturer Street3050 EAST HILLCREST DRIVE
Manufacturer CityTHOUSAND OAKS, CA
Manufacturer CountryUS
Manufacturer Phone4443300357
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEGACY HEALING COLLAR
Generic NameDENTAL IMPLANT
Product CodeNHA
Date Received2020-03-31
Returned To Mfg2020-03-11
Model Number8530-15
Catalog Number8530-15
Lot Number148717
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerIMPLANT DIRECT SYBRON MANUFACTURING LLC
Manufacturer Address3050 EAST HILLCREST DRIVE THOUSAND OAKS, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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