MAUDE Adverse Event Report: INTEGRUM AB OPRA FIXTURE; FIXTURE BIOHELIX 22X80

Model Number	1348
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Fixture loosening.No deviation in batch documentation.Device has been manufactured according to specifications.According to report form the cause of failure is unknown.Blood and tissue samples were taking during the extraction procedure to evaluate the possible presence of deep infection.
Additional Manufacturer Narrative
Fixture loosening.No deviation in batch documentation.Device has been manufactured according to specifications.According to report form from surgeon the cause of failure is unknown.Culture samples were taking during the fixture removal procedure.Results showed that an infection could not be excluded.This is a case where it is difficult to draw any final conclusion.However, the investigation/findings suggest that the failure is not related to device manufacturing issues.
Event or Problem Description
Fixture loosening.No deviation in batch documentation.Device has been manufactured according to specifications.According to report form the cause of failure is unknown.Blood and tissue samples were taking during the extraction procedure to evaluate the possible presence of deep infection.New information 11/21/2018: culture results showed that one out of 5 cultures were positive, which means that an infection could not be excluded.This is a case where it is difficult to draw any final conclusion.However, the investigation/findings suggest that the failure is not related to manufacturing issues.

• Brand Name: OPRA FIXTURE
• Common Device Name: FIXTURE BIOHELIX 22X80
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, vastra gotaland 43137 ; SW 43137
• MDR Report Key: 8071726
• Report Number: 3011386779-2018-00016
• Device Sequence Number: 11158593
• Product Code: PJY
• UDI-Device Identifier: 07340152100115
• UDI-Public: 07340152100115
• 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: 2015
• 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): 11/21/2018
• Report Date (Section F): 10/08/2018

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: No Information
• Device Expiration Date: 05/01/2019
• Device Model Number: 1348
• Device Catalogue Number: 1348
• Device Lot Number: P243445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2018
• Device Age: 42 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/26/2018
• 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