SAGITTAL BLADE 2108218000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-22 for SAGITTAL BLADE 2108218000 manufactured by Stryker Ireland Ltd..

Event Text Entries

[1438092] It was reported that the blade edges had perforated the sterile packaging. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


[8597003] There were a number of items associated with this complaint. It can be confirmed from visual inspection that product packaging is damaged. Other complaints have been received reporting similar events. A secondary polybag has been introduced into the packaging configuration of these products to address this issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9616696-2010-00176
MDR Report Key1625711
Report Source07
Date Received2010-02-22
Date of Report2009-07-22
Date of Event2009-07-20
Date Mfgr Received2009-07-22
Date Added to Maude2011-02-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactUNA
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Manufacturer Phone214532963
Manufacturer G1STRYKER IRELAND LTD.
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAGITTAL BLADE
Generic NameSAW BLADES AND ACCESSORIES
Product CodeDWH
Date Received2010-02-22
Catalog Number2108218000
Lot Number09106027
Device Expiration Date2014-04-01
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER IRELAND LTD.
Manufacturer AddressCARRIGTWOHILL, CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-22

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