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

Model Number	IBC0012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fixture is not returned to integrum after removal.
Event or Problem Description
On 05/22/2020: integrum received information regarding fixture removal surgery to be performed in the end of (b)(6).Surgery performed (b)(6) 2020.It was reported that: fixture was well integrated and that the surgeon does not think the implant system was the cause of the infection rather the pre operative oi history which had some issues - removal of bone cement in preparation for oi back in 2009.No other information obtained.
Event or Problem Description
(b)(6) 2020: integrum received information regarding fixture removal surgery to be performed in the end of(b)(6).Surgery performed (b)(6) 2020.It was reported that: fixture was well integrated and that the surgeon does not think the implant system was the cause of the infection rather the pre operative oi history which had some issues - removal of bone cement in preparation for oi back in 2009.No other information obtained.(b)(6) 2020: batch documentation reviewed, no deviations found.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: FIXTURE
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 10217161
• Report Number: 3011386779-2020-00033
• Device Sequence Number: 2404325
• Product Code: PJY
• UDI-Device Identifier: 07340152100443
• UDI-Public: 07340152100443
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: H080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 12/15/2020
• Report Date (Section F): 05/29/2020

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 Model Number: IBC0012
• Device Catalogue Number: IBC0012
• Device Lot Number: 95802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 19 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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