ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 10? IR5236P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-08 for ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 10? IR5236P manufactured by Ldr Medical.

MAUDE Entry Details

• Report Number: 3004788213-2019-00316
• MDR Report Key: 9297595
• Report Source: DISTRIBUTOR,HEALTH PROFESSION
• Date Received: 2019-11-08
• Date of Report: 2019-11-08
• Date of Event: 2019-10-09
• Date Mfgr Received: 2019-10-09
• Date Added to Maude: 2019-11-08
• 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: MS. FLORENCE MAILY
• Manufacturer Street: QUARTIER EUROPE DE L 5, RUE DE BERLIN
• Manufacturer City: SAINTE-SAVINE, NA 10300
• Manufacturer Country: FR
• Manufacturer Postal: 10300
• Manufacturer Phone: 33382803
• Manufacturer G1: LDR MEDICAL
• Manufacturer Street: QUARTIER EUROPE DE L 5, RUE DE BERLIN
• Manufacturer City: SAINTE-SAVINE, NA 10300
• Manufacturer Country: FR
• Manufacturer Postal Code: 10300
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 10?
• Generic Name: ROI-A ALIF CAGE SYSTEM
• Product Code: MAX
• Date Received: 2019-11-08
• Model Number: NA
• Catalog Number: IR5236P
• Lot Number: 12-290833R18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LDR MEDICAL
• Manufacturer Address: QUARTIER EUROPE DE L?OUEST 5, RUE DE BERLIN SAINTE-SAVINE, NA 10300 FR 10300

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-08