MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OPRA IMPLANT SYSTEM - FIXTURE 17X80

Model Number IBC0010

Device Problem Loss of Osseointegration (2408)

Patient Problem Osteomyelitis (4533)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Removed fixtures are not returned to integrum for investigation.The information regarding the case will be obtained by communication with the treating team.

Event Description

2021-07-07: qa has been notified in june about a potential fixture removal of one patient due to osteomyelitis planned in chile.The surgery date was set (b)(6) 2021.No information on sn/lot of the fixture is available and has not been provided by the treating team.The patient was implanted 2011 and the fixture removal surgery does not concern the platform g introduced on the market in 2017.Sales team at (b)(6) has provided the treating team with the surgical manual for abutment extraction an fixture removal (b)(6) , while the instruments needed for the removal surgery on (b)(6) 2021.More information is expected after surgery is performed on (b)(6).No information provided yet.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: OPRA IMPLANT SYSTEM - FIXTURE 17X80
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sally skog ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12165597
• MDR Text Key: 261440749
• Report Number: 3011386779-2021-00054
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100429
• UDI-Public: 07340152100429
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: IBC0010
• Device Catalogue Number: IBC0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization