ORMCO C-TYPE RELEASE MODULES 715-2020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-03-17 for ORMCO C-TYPE RELEASE MODULES 715-2020 manufactured by Ormco Corp..

Event Text Entries

[123400] This report was rec'd via the orthodontist who reported that the c-type release modules would not easily release from the c-clip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-1998-00002
MDR Report Key157711
Report Source05
Date Received1998-03-17
Date of Report1998-01-15
Date of Event1998-01-01
Date Mfgr Received1998-03-10
Device Manufacturer Date1997-10-01
Date Added to Maude1998-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameORMCO C-TYPE RELEASE MODULES
Generic NameRELEASE MODULES USED WITH ORTHODONTIC HEADGEAR
Product CodeDZB
Date Received1998-03-17
Returned To Mfg1998-01-21
Model NumberNA
Catalog Number715-2020
Lot Number7L1
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key153656
ManufacturerORMCO CORP.
Manufacturer Address1332 S. LONE HILL AVE. GLENDORA CA 91740 US
Baseline Brand NameC-TYPE RELEASE MODULES
Baseline Generic NameRELEASE MODULES USED WITH ORTHODONTIC HEADGEAR
Baseline Model NoNA
Baseline Catalog No715-2020
Baseline IDNA
Baseline Device FamilyEXTRAORAL ORTHODONTIC HEADGEAR
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK902645
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1998-03-17

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