ASTRA TECH 4.5X11 REF# 24532

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-30 for ASTRA TECH 4.5X11 REF# 24532 manufactured by Astra.

Event Text Entries

[4712996] Astra tech. Fractured dental x 3.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5037696
• MDR Report Key: 4002576
• Date Received: 2014-07-30
• Date Added to Maude: 2014-08-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ASTRA TECH
• Generic Name: DENTAL IMPLANTS
• Product Code: NSO
• Date Received: 2014-07-30
• Model Number: 4.5X11
• Catalog Number: REF# 24532
• Lot Number: 31145
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASTRA
• Manufacturer Address: 590 LINCOLN ST. WALTHAM MA 02451 US 02451

Device Sequence Number: 2

• Brand Name: ASTRA TECH
• Generic Name: DENTAL IMPLANTS
• Product Code: NSO
• Date Received: 2014-07-30
• Model Number: 4.5X11
• Catalog Number: REF#: 24532
• Lot Number: 31145
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ASTRA
• Manufacturer Address: 590 LINCOLN ST. WALTHAM MA 02451 US 02451

Device Sequence Number: 3

• Brand Name: ASTRA TECH
• Generic Name: DENTAL IMPLANTS
• Product Code: NSO
• Date Received: 2014-07-30
• Model Number: 4.5X9
• Catalog Number: REF#: 24531
• Lot Number: 29387
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ASTRA
• Manufacturer Address: 590 LINCOLN ST. WALTHAM MA 02451 US 02451

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2014-07-30