DOVETOME 30-0265

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-31 for DOVETOME 30-0265 manufactured by Cortek, Inc..

Event Text Entries

[15710882] Osteotome blade broke during anterior spinal procedure. Broken blade lodged in bone and was removed during the surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1226193-2000-00001
• MDR Report Key: 272540
• Report Source: 05
• Date Received: 2000-03-31
• Date of Report: 2000-03-31
• Date of Event: 2000-03-02
• Date Mfgr Received: 2000-03-02
• Device Manufacturer Date: 2000-02-01
• Date Added to Maude: 2000-04-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Street: 990 WASHINGTON ST
• Manufacturer City: DEDHAM MA 02026
• Manufacturer Country: US
• Manufacturer Postal: 02026
• Manufacturer Phone: 7814070020
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DOVETOME
• Generic Name: OSTEOTOME
• Product Code: GFI
• Date Received: 2000-03-31
• Returned To Mfg: 2000-03-03
• Model Number: NA
• Catalog Number: 30-0265
• Lot Number: 0094
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 263845
• Manufacturer: CORTEK, INC.
• Manufacturer Address: 990 WASHINGTON ST. DEDHAM MA 02026 US
• Baseline Brand Name: DOVETOME
• Baseline Generic Name: OSTEOTOME
• Baseline Catalog No: 30-0265
• Baseline Device Family: DOVETOME
• Baseline Shelf Life Contained: N
• 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	1. Other	2000-03-31