MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE BIOHELIX 16X80

Model Number	1800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Fixture loosening, deep infection.Probably cause unknown according to surgeon.At surgery a bad pressfit is discovered.Play between components with tightened abutment screw.(b)(4).The product performance will not be affected according to concession documentation.
Event or Problem Description
Fixture loosening deep infection.Probably cause unknown according to surgeon.At surgery a bad pressfit is discovered.Play between components with tightened abutment screw.Batch documentation reviewed (b)(4).Fixtures released with concession doc reg 007778.The product performance will not be affected according to concession documentation.Update 2019-02-12: visual inspection of the abutment has identify contact during use all around the press fit surface with no signs of deviation.The case for extraction is related to infection after approx.1 year of implantation and therefore not considered an early failure.There was no deviation found in the batch documentation that could be related to the failure mode of the fixture.There is no need to further investigate the case since the reason of the failure has been identified as a deep infection with unknown cause and no deviation has been found in the batch documentation.
Additional Manufacturer Narrative
The reason of the failure has been identified as a deep infection with unknown cause and no deviation has been found in the batch documentation.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: FIXTURE BIOHELIX 16X80
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, vastra gotaland 43137 ; SW 43137
• MDR Report Key: 8182324
• Report Number: 3011386779-2018-00018
• Device Sequence Number: 11243626
• Product Code: PJY
• UDI-Device Identifier: 07340152100177
• UDI-Public: 07340152100177
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: H080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019
• Report Date (Section F): 12/04/2018

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: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 1800
• Device Catalogue Number: 1800
• Device Lot Number: R5370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2018
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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