IDUO G2 M5723INT0600210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for IDUO G2 M5723INT0600210 manufactured by Conformis, Inc..

Event Text Entries

[51147728] The disposable tibial impactor tip became lodged in the disposable impactor handle and broke off in the impactor handle during attempts to remove the tip. This caused an inconvenience during the surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004153240-2016-00152
• MDR Report Key: 5823676
• Date Received: 2016-07-26
• Date of Report: 2016-07-26
• Date of Event: 2016-06-27
• Date Mfgr Received: 2016-06-28
• Device Manufacturer Date: 2016-06-16
• Date Added to Maude: 2016-07-26
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARINA SNOW
• Manufacturer Street: 28 CROSBY DRIVE
• Manufacturer City: BEDFORD MA 01730
• Manufacturer Country: US
• Manufacturer Postal: 01730
• Manufacturer Phone: 7813459195
• Manufacturer G1: CONFORMIS, INC.
• Manufacturer Street: 600 RESEARCH DRIVE
• Manufacturer City: WILMINGTON MA 01887
• Manufacturer Country: US
• Manufacturer Postal Code: 01887
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: IDUO G2
• Generic Name: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Product Code: OOG
• Date Received: 2016-07-26
• Catalog Number: M5723INT0600210
• Device Expiration Date: 2016-12-31
• Operator: PHYSICIAN
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONFORMIS, INC.
• Manufacturer Address: 28 CROSBY DRIVE BEDFORD MA 01730 US 01730

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-26