SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT. 9048-49

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 2020-03-24 for SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT. 9048-49 manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[186541128] This complaint was identified internally and generated for ncmr 10279. Per the ncmr, the part will be destroyed.
Patient Sequence No: 1, Text Type: N, H10


[186541129] Per complaint (b)(4), during an internal review, a part was identified as missing a label.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2020-02949
MDR Report Key9873302
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2019-08-02
Date Mfgr Received2019-08-02
Device Manufacturer Date2019-05-13
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
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 NameSWISH TITANIUM NON-ENGAGING TEMPORARY ABUT.
Generic NameDENTAL IMPLANT
Product CodeNHA
Date Received2020-03-24
Returned To Mfg2019-08-02
Model Number9048-49
Catalog Number9048-49
Lot Number142088
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-03-24

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