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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM
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INTEGRUM AB OPRA IMPLANT SYSTEM Back to Search Results
Model Number 1820
Device Problem Unclear Information (4052)
Patient Problem Fall (1848)
Event Date 06/23/2021
Event Type  Injury  
Event Description
2021-06-23: qa at integrum has become aware about a patient scheduled for a surgery due to abutment fracture with bent abutment screw.The probable cause is trauma which has been communicated with sales rep at int inc., but no details had been specified.As per info provided via report form, the patient fell while walking upstairs with his prosthetic foot stepped on a chip sticking out from the ground.The patient fell on his abutment when fail safe activated.Integrum ab is following up via sales rep to get more information needed to understand the case.2021-07-07: the replaced product was sent back to iab on june 30th, yet not received yet.Technical analysis to be performed once the part is delivered.Manufacturing batch has been reviewed and no deviation related to the product was found.
 
Event Description
2021-06-23: qa at integrum has become aware about a patient scheduled for a surgery due to abutment fracture with bent abutment screw.The probable cause is trauma which has been communicated with sales rep at int inc., but no details had been specified.As per info provided via report form, the patient fell while walking upstairs with his prosthetic foot stepped on a chip sticking out from the ground.The patient fell on his abutment when fail safe activated.Integrum ab is following up via sales rep to get more information needed to understand the case.2021-07-07: the replaced product was sent back to iab on (b)(6), yet not received yet.Technical analysis to be performed once the part is delivered.Manufacturing batch has been reviewed and no deviation related to the product was found.2021-09-01: parts have been received at integrum.Visual inspection of the retrieved components indicate a sudden fracture.The abutment screw is bent and stuck inside the distal part of the abutment which suggest further suggest that the system has been subjected to high loads, fracturing the abutment and bending the abutment screw during the fall.The cause of the failure is known, and there is no need of further investigation.
 
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Brand Name
OPRA IMPLANT SYSTEM
Type of Device
OPRA IMPLANT SYSTEM
Manufacturer (Section D)
INTEGRUM AB
krokslatts fabriker 50
molndal, 43137
SW  43137
MDR Report Key12165590
MDR Text Key261444482
Report Number3011386779-2021-00053
Device Sequence Number1
Product Code PJY
UDI-Device Identifier07340152100726
UDI-Public07340152100726
Combination Product (y/n)N
PMA/PMN Number
P190009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/01/2023
Device Model Number1820
Device Catalogue Number1820
Device Lot Number7600/P804606
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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