MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OPRA IMPLANT FIXTURE 18MM

Model Number	IBC0012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Integrum was informed 9th of january about fixture loosening (fixture will be removed).Patient has had a history of infections and pain.Infection will be treated by debridement, local and systemic antibiotics.Fixture has been removed in surgery and will not be replaced.No further information will be obtained.Since fixture will not be returned to integrum.
Event or Problem Description
9th of january 2020 integrum received information that patient will remove fixture due to fixture loosening.Patient has had a history of infections and pain.Infection will be treated by debridement, local and systemic antibiotics.Batch documentation reviewed.No deviations found in product.Patient had the implant for 14 years and therefore this is not considered an early failure.4t og (b)(6) 2020 fixture removal surgery performed.Fixture will not be replaced.No further information will be obtained.
Additional Manufacturer Narrative
Integrum was informed 9th of january about fixture loosening (fixture will be removed).Patient has had a history of infections and pain.Infection will be treated by debridement, local and systemic antibiotics.Fixture has been removed in surgery and will not be replaced.No further information will be obtained.Since fixture will not be returned to integrum.Correction: 7th of february.Section d7 updated with correct explant date, due to typo.
Event or Problem Description
9th of january 2020 integrum received information that patient will remove fixture due to fixture loosening.Patient has had a history of infections and pain.Infection will be treated by debridement, local and systemic antibiotics.Batch documentation reviewed.No deviations found in product.Patient had the implant for 14 years and therefore this is not considered an early failure.On (b)(6) 2020, fixture removal surgery performed.Fixture will not be replaced.No further information will be obtained.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT FIXTURE 18MM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 9678162
• Report Number: 3011386779-2020-00028
• Device Sequence Number: 2396509
• Product Code: PJY
• UDI-Device Identifier: 07340152100443
• UDI-Public: 07340152100443
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: H080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 10/01/2007
• Device Model Number: IBC0012
• Device Catalogue Number: IBC0012
• Device Lot Number: 20020829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/10/2020
• 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: Required Intervention