NOBELPARALLEL CC RP 4.3X8.5MM 37971

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for NOBELPARALLEL CC RP 4.3X8.5MM 37971 manufactured by Nobel Biocare Ab.

Event Text Entries

[185884828] Implant failed due to a loss of osseointegration.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027971-2020-08897
MDR Report Key9907600
Date Received2020-03-31
Date of Event2020-03-12
Date Facility Aware2020-03-28
Report Date2020-03-31
Date Reported to FDA2020-03-31
Date Added to Maude2020-03-31
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOBELPARALLEL CC RP 4.3X8.5MM
Generic NameENDOSSEOUS DENTAL IMPLANT
Product CodeDZE
Date Received2020-03-31
Catalog Number37971
Lot Number12083457
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1098 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNOBEL BIOCARE AB
Manufacturer AddressDIMBOV?GEN 2 KARLSKOGA 69151 SE 69151


Patients

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

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