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 Number: 169695
• MDR Report Key: 169695
• Date Received: 1998-05-29
• Date of Report: 1998-04-20
• Date of Event: 1998-04-14
• Date Facility Aware: 1998-04-14
• Report Date: 1998-04-20
• Date Reported to Mfgr: 1998-04-21
• Date Added to Maude: 1998-06-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: V. MUELLER
• Generic Name: STRAIGHT CURRETTE
• Product Code: FZS
• Date Received: 1998-05-29
• Model Number: *
• Catalog Number: AV11308
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 165066
• Manufacturer: ALLEGIANCE
• Manufacturer Address: 1425 LAKE COOK RD. DEERFIELD IL 60015 US
• Baseline Brand Name: LEMPERT CURETTE SZ 00
• Baseline Generic Name: CURETTE
• Baseline Model No: AU11308
• Baseline Catalog No: AU11308
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-05-29