LOCATOR DRILL LDRILL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-08 for LOCATOR DRILL LDRILL manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[135724141] Per complaint (b)(4), a vial for a step drill was packaged with a cortical bone drill.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2019-00050
MDR Report Key8324306
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-02-08
Date of Report2019-03-20
Date of Event2019-01-01
Date Mfgr Received2019-03-12
Device Manufacturer Date2018-11-05
Date Added to Maude2019-02-08
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 91362
Manufacturer CountryUS
Manufacturer Postal91362
Manufacturer Phone8184443300
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLOCATOR DRILL
Generic NameLOCATOR DRILL
Product CodeDZI
Date Received2019-02-08
Returned To Mfg2019-02-08
Catalog NumberLDRILL
Lot Number127062
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIMPLANT DIRECT SYBRON MANUFACTURING LLC
Manufacturer Address3050 EAST HILLCREST DRIVE THOUSAND OAKS CA 91362 US 91362


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-08

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