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

Model Number	IBC0010
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646); Osteomyelitis (4533); Implant Pain (4561)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
More information to be obtained regarding the incident and the patient status.
Event or Problem Description
It has been reported to the integrum 15th of september that a fixture removal surgery has been performed 14th of september.The patient has had the fixture for more than 8 years.Patient has had history of bone loss around the implant.No report form or information received regarding the incident or the reason behind the fixture removal.
Event or Problem Description
On (b)(6) 2020: it has been reported to the integrum (b)(6) that a fixture removal surgery has been performed (b)(6).The patient has had the fixture for more than 8 years.Patient has had history of bone loss around the implant.No report form or information received regarding the incident or the reason behind the fixture removal.No more information except for the date of the surgery when the fixture removal was performed.The treating doctor has been requested on (b)(6) 2020 to send the report form filled in.Implant has not been delivered yet.2020-10-16: abutment has been returned to integrum.It has been reported to the integrum that a fixture removal surgery has been performed.The patient has had the fixture for more than 8 years.Patient has had history of bone loss around the implant, osteomyelitis.No report form or information received regarding the incident or the reason behind the fixture removal.During the surgery (b)(6) the fixture was removed and it was reported that the bone was hard and the fixture tuff to remove witch indicate that the remaining part was well osseointegrated.Qa has requested more information regarding the fixture removal.2020-10-24: the sales representative informs qa that the bone resorption has increased over the years.It had increased to the extent that the distal part of the fixture was visible.The treating surgeon dr marion bertrand marchand has tried several treating options.2018 february she informed that she will try with the plastic surgeon to make a flap to cover the distal resorption of the bone.2018 (b)(6) deep culture was taken to rule out deep infection.X-rays has been taken in (b)(6) 2019 the x-ray.It indicated that resorption had increased 11-12 turns.In (b)(6) 2020 the resoprion had increased 12 till 13 turns, even during antibiotic treatment.In beginning of (b)(6) 2020 integrum had an ongoing discussion to try produce a distal cap of the fixture to see if it could work.But since it has not been tried before this was ruled out as an option since the patient wanted to remove the fixture.I the end of end (b)(6) 2020 dr marion bertrand merchand reported that the patient has a lot of pain and would like to remove the implant.The report form was never sent in to integrum.
Additional Manufacturer Narrative
More information to be obtained regarding the incident and the patient status.February 8th 2021: additional information and codes added.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: FIXTURE 17X80 PLATFORM F
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 10693138
• Report Number: 3011386779-2020-00037
• Device Sequence Number: 11689613
• Product Code: PJY
• UDI-Device Identifier: 07340152100429
• UDI-Public: 07340152100429
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2021

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 Expiration Date: 01/10/2015
• Device Model Number: IBC0010
• Device Catalogue Number: IBC0010
• Device Lot Number: P116617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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: Other