CURETTE, ANGLED, 5-0, 229 MM * R-0374

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-26 for CURETTE, ANGLED, 5-0, 229 MM * R-0374 manufactured by Logan Instruments Inc..

Event Text Entries

[671599] The user facility reported during a spinal procedure in 2007, the physician had the tip of the device break off inside the patient. Additional information: the device was purchased in 2003. It was observed the device broke during the surgery, and the time surgery had to be extended could not be determined.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2430952-2007-00015
MDR Report Key888826
Date Received2007-07-26
Date of Report2007-06-08
Date of Event2007-04-10
Date Facility Aware2007-05-09
Report Date2007-06-08
Date Added to Maude2007-08-06
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCURETTE, ANGLED, 5-0, 229 MM
Generic NameSURGICAL INSTRUMENT
Product CodeFZS
Date Received2007-07-26
Model Number*
Catalog NumberR-0374
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key866348
ManufacturerLOGAN INSTRUMENTS INC.
Manufacturer Address* EVERETTE MA * US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-07-26

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