SYSTEM 5 SAGITTAL SAW 4208000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-11 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[19353932] It was reported that the device is not working during a procedure and there was a delay of 30 minutes to get the back up device. The procedure was completed successfully. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[19628968] The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed. Failure analysis is in progress.
Patient Sequence No: 1, Text Type: N, H10


[75931778]
Patient Sequence No: 1, Text Type: N, H10


[75931779] It was reported that the device is not working during a procedure and there was a delay of 30 minutes to get the back up device. The procedure was completed successfully. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2015-02089
MDR Report Key4837686
Report Source06,USER FACILITY
Date Received2015-06-11
Date of Report2017-05-25
Date of Event2015-05-14
Date Mfgr Received2015-09-29
Device Manufacturer Date2003-02-06
Date Added to Maude2015-06-11
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 ContactMR. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYSTEM 5 SAGITTAL SAW
Generic NameINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Product CodeKIJ
Date Received2015-06-11
Returned To Mfg2015-06-02
Catalog Number4208000000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.