MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPANT SYSTEM

Device Problem Osseointegration Problem (3003)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/13/2021

Event Type  Injury  

Event Description

Tfaos study 18-25641, patient (b)(6) previously had deep infection confirmed and was treated intravenously with antibiotics.The deep infection is handled in case 486 (report id: (b)(4)).Patient (b)(6) presented to a local emergency department in (b)(6) on (b)(6) 2021 for right upper extremity pain and swelling.An ultrasound examination revealed deep venous pericatheter thrombosis involving the axillary, and subclavian veins with superficial thrombophlebitis of the basilic vein.The patient's picc line, which had been placed for administration of intravenous antibiotics for management of his deep implant infection, was removed.The patient was bridged from enoxaparin from warfarin for anticoagulation.After discharge, the patient developed back pain and difficulty breathing.A ct scan on (b)(6) 2021 showed "right lower lobe segmental and subsegmental pulmonary emboli," and the patient was readmitted to the hospital in rhode island.The plan is to follow up with dr.Carty at brigham and womens hospital as an outpatient.The patient also has a video visit scheduled with the ucsf osseointegration clinic on (b)(6) 2021.This instance of picc line-related deep venous thrombosis and pulmonary embolism, which is a complication of deep infection management, occurring remote from the study's operative and rehabilitative procedures would not effect research participants' willingness to participate.Blood clots are always discussed by the ucsf pis with patients as part of the shared decision making process prior to surgery.The possiblity of blood clots as a complication of picc line usage would have been discussed, as a matter of routine, by the patients medical providers at the brigham and womens hospital.Since deep periimplant infection, a known complication of osseointegration surgery, occcurs at a relatively low rate (3/18 or 16.7% in our experience); since deep venous thrombosis occurs rarely after picc line insertion (perhaps 1% of the time); and since pulmonary embolism occurs rarely after upper extremity venous thrombosis (perhaps 1% of the time), it is unlikely that this very rare occurence would effect research participants' willingness to participate in this study.

• Brand Name: OPRA IMPANT SYSTEM
• Type of Device: OPRA IMPANT SYSTEM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sally skog ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12083875
• MDR Text Key: 266920015
• Report Number: 3011386779-2021-00051
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/29/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention