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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPANT SYSTEM
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INTEGRUM AB OPRA IMPANT SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 04/08/2021
Event Type  Injury  
Event Description
On 2021-04-19: integrum was notified via e-mail received aril 12th, 2021 about a tfaos patient with a deep infection in the bone.As clinical sign swelling of a residual limb concluded as apparent deep infection has been reported.According to information provided, the patient has developed further evidence of infection, previously reported in april 2020, may 2020 and january 2021.Ct scans were obtained on (b)(6) and the patient received an oral antibiotic treatment.A tentative plan has been agreed to proceed with operative debridement.There is no information about the sn or lot of the product.Case will be followed up once additional info is provided.
 
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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 Key11706144
MDR Text Key247769443
Report Number3011386779-2021-00050
Device Sequence Number1
Product Code PJY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190009
Number of Events Reported1
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 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
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
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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