OSCILLATING SAW RETROFIT 0296-319-000 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-02-26 for OSCILLATING SAW RETROFIT 0296-319-000 NA manufactured by Stryker Instruments.

Event Text Entries

[41363] Oil leaking out. Pt was given antibiotics and the site was debrided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1811755-1997-00025
MDR Report Key72790
Report Source06
Date Received1997-02-26
Date Mfgr Received1997-01-30
Device Manufacturer Date1991-04-01
Date Added to Maude1997-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOSCILLATING SAW RETROFIT
Generic NameSAW
Product CodeDZH
Date Received1997-02-26
Model Number0296-319-000
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age6 YR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key72652
ManufacturerSTRYKER INSTRUMENTS
Manufacturer Address4100 E. MILHAM AVE. KALAMAZOO MI 49001 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-02-26

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