11G IVAS ACCESS CANNULA 0306330000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-22 for 11G IVAS ACCESS CANNULA 0306330000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[83215306] It was reported that the needle of the device broke off in the patient during the procedure. There was no attempt to remove the device material left behind and the procedure was successfully completed with no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2017-01765
MDR Report Key6809717
Report SourceUSER FACILITY
Date Received2017-08-22
Date of Report2018-02-14
Date of Event2017-07-24
Date Mfgr Received2018-01-24
Device Manufacturer Date2017-06-07
Date Added to Maude2017-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ZACHARY BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-PUERTO RICO
Manufacturer StreetLAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2
Manufacturer CityARROYO 00615
Manufacturer Postal Code00615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name11G IVAS ACCESS CANNULA
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeOAR
Date Received2017-08-22
Catalog Number0306330000
Lot Number17158012
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-22

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