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

Model Number	IBC0010
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: OPRA IMPLANT SYSTEM - FIXTURE 17X80
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12165597
• Report Number: 3011386779-2021-00054
• Device Sequence Number: 3782320
• Product Code: PJY
• UDI-Device Identifier: 07340152100429
• UDI-Public: 07340152100429
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: IBC0010
• Device Catalogue Number: IBC0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization