CODMAN LAMINECTOMY RONGEURS N/A 53-1047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-09 for CODMAN LAMINECTOMY RONGEURS N/A 53-1047 manufactured by Codman.

Event Text Entries

[19160666] Patient had a right l5-s1 hernated nucleaus pulposus and was admitted to have a microscopic l5-s1 disectomy on the right. During the operative procedure,a duckbill type of ronger was being used to remove a part of the lamina and the duckbill rongeur superior lip broke off at the screw, and ejected into the dura just to the right of midline. The tip was removed and the tear was easily repaired.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number10132
MDR Report Key10132
Date Received1993-08-09
Date of Report1993-07-20
Date of Event1993-07-07
Date Facility Aware1993-07-07
Report Date1993-07-20
Date Reported to FDA1993-07-26
Date Reported to Mfgr1993-07-09
Date Added to Maude1993-09-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCODMAN LAMINECTOMY RONGEURS
Product CodeEMH
Date Received1993-08-09
Model NumberN/A
Catalog Number53-1047
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age8 YR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key10132
ManufacturerCODMAN
Manufacturer Address41 PACELLA PARK DRIVE RANDOLPH MA 02368 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-08-09

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