V. MUELLER * AV11308

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-29 for V. MUELLER * AV11308 manufactured by Allegiance.

Event Text Entries

[21395441] Neuro currette split during lumbar laminectomy; small piece broke off and was removed from surgical field. Surgeon confirmed that no pieces of instrument remained in incision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number169695
MDR Report Key169695
Date Received1998-05-29
Date of Report1998-04-20
Date of Event1998-04-14
Date Facility Aware1998-04-14
Report Date1998-04-20
Date Reported to Mfgr1998-04-21
Date Added to Maude1998-06-01
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 NameV. MUELLER
Generic NameSTRAIGHT CURRETTE
Product CodeFZS
Date Received1998-05-29
Model Number*
Catalog NumberAV11308
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key165066
ManufacturerALLEGIANCE
Manufacturer Address1425 LAKE COOK RD. DEERFIELD IL 60015 US
Baseline Brand NameLEMPERT CURETTE SZ 00
Baseline Generic NameCURETTE
Baseline Model NoAU11308
Baseline Catalog NoAU11308
Baseline IDNA
Baseline Device FamilyINSTRUMENT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1998-05-29

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