MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OSSEOANCHORED PROSTHESES FOR THE REHABILITATION OF TRANSFEMORAL AMPUTEES

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It's been an ongoing problem with this device, opra implant, my own opra device, it's in for repairs, the first one was replace, the second opra device, "i'd in for repairs?".The problem i was told that the screws were damage or caning apart, now i have a loaner # (b)(6), this one is hard to detach from my stump screws, and when it dose it has a very loud noise, and it is painful when it on screws from the screw that is connected to the bone, it pops.Ref report: mw5148439.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: OSSEOANCHORED PROSTHESES FOR THE REHABILITATION OF TRANSFEMORAL AMPUTEES
• Manufacturer (Section D): INTEGRUM AB
• MDR Report Key: 18204734
• MDR Text Key: 329066024
• Report Number: MW5148440
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Patient Race: White