OPRA IMPLANT SYSTEM IBC0015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-22 for OPRA IMPLANT SYSTEM IBC0015 manufactured by Integrum Ab.

MAUDE Entry Details

• Report Number: 3011386779-2019-00025
• MDR Report Key: 9221489
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-22
• Date of Report: 2019-09-24
• Date of Event: 2019-09-18
• Report Date: 2019-09-24
• Date Reported to Mfgr: 2019-09-24
• Date Mfgr Received: 2019-09-24
• Device Manufacturer Date: 2010-12-08
• Date Added to Maude: 2019-10-22
• 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: MR NIKLAS HOFVERBERG
• Manufacturer Street: KROKSLATTS FABRIKER 50
• Manufacturer City: MOLNDAL, 43137
• Manufacturer Country: SW
• Manufacturer Postal: 43137
• Manufacturer G1: INTEGRUM AB
• Manufacturer Street: KROKSLATTS FABRIKER 50
• Manufacturer City: MOLNDAL, 43137
• Manufacturer Country: SW
• Manufacturer Postal Code: 43137
• Single Use: 3
• Remedial Action: PM
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPRA IMPLANT SYSTEM
• Generic Name: OPRA IMPLANT FIXTURE 19,5*80
• Product Code: PJY
• Date Received: 2019-10-22
• Model Number: IBC0015
• Catalog Number: IBC0015
• Lot Number: 116617
• Device Expiration Date: 2015-09-10
• Device Availability: N
• Device Age: 6 YR
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRUM AB
• Manufacturer Address: KROKSLATTS FABRIKER 50 MOLNDAL, 43137 SW 43137

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-22