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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM AB AXOR II; OPRA IMPLANT SYSTEM
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INTEGRUM AB AXOR II; OPRA IMPLANT SYSTEM Back to Search Results
Model Number 1288
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problems Fall (1848); No Code Available (3191)
Event Date 07/18/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing batch documentation investigation shows no deviation.The device has been manufactured according to specifications.Tha device has been in use for approx 10 months.A capa is ongoing to find root cause of the problem.[(b)(4)].
 
Event Description
Mail: the axor ii device dislodged from the abutment, causing the external prosthesis to fall off.The patient, who was walking in a retail store at the time, fell and sustained bruising.The patient informed us of this incident today.(b)(4) has already informed (b)(4) who is working on supplying the patient with a loaner unit.(b)(4) instructed the patient not to use her current axor unit.She will remain on crutches.Adverse report from clinician.The patient called to state that the axor failsafe component disassociated from the abutment, the prosthesis fell off, and she fell to the ground while walking in a store.She states that she bruised herself badly.Over the past week, she had experienced axor loosening despite her best attempts.
 
Event Description
Mail: the axor ii device dislodged from the abutment, causing the external prosthesis to fall off.The patient, who was walking in a retail store at the time, fell and sustained bruising.The patient informed us of this incident today.Matthew garibaldi has already informed kurt collier who is working on supplying the patient with a loaner unit.Matthew instructed the patient not to use her current axor unit.She will remain on crutches.Adverse report from clinician.The patient called to state that the axor failsafe component disassociated from the abutment, the prosthesis fell off, and she fell to the ground while walking in a store.She states that she bruised herself badly.Over the past week she had experienced axor loosening despite her best attempts.
 
Manufacturer Narrative
Manufacturing batch documentation investigation shows no deviation.The device has been manufactured according to specifications.Tha device has been in use for approx 10 months.A capa is ongoing to find root cause of the problem.New information (b)(6) 2018.The investigation of the device showned no devations.The device was performing as expected.During the patient interview it was reported significant body fluid secreation.The ongoing capa investigation has identified that this could be a possible cause contributing to the detachment.It is recommended in the instructions for use to perform regular cleaning of the device according to the new instruction video for axor donning doffing and cleaning.(b)(4).
 
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Brand Name
AXOR II
Type of Device
OPRA IMPLANT SYSTEM
Manufacturer (Section D)
INTEGRUM AB
krokslätts fabriker 50
mölndal, gothenburg 43137
SW  43137
MDR Report Key7796960
MDR Text Key117855258
Report Number3011386779-2018-00007
Device Sequence Number1
Product Code PJY
UDI-Device Identifier07340152100634
UDI-Public07340152100634
Combination Product (y/n)N
PMA/PMN Number
HDE H080004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/18/2018,08/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number1288
Device Catalogue Number1288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/18/2018
Device Age15 MO
Event Location Other
Date Report to Manufacturer07/18/2018
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 YR
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