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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN-VIVO INTRAMEDULLARY FIXATION ROD

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ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN-VIVO INTRAMEDULLARY FIXATION ROD Back to Search Results
Catalog Number USSL-1700260
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
The original surgeon responsible for implanting the illuminoss device is no longer at the hospital where the procedure occurred.The surgeon who is now caring for the patient in question, had inquired about the illuminoss device and whether they could drill into the device and revise the fracture, as they were unfamiliar with the implant material.Very little information has been obtained regarding the patient's current condition and whether a revision was done.Additional information is being requested.
 
Event Description
A report was received on (b)(6) 2018 that an illuminoss implant had fractured post-operatively.It is unknown as to the cause or whether this issue was found during a routine follow-up.
 
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Brand Name
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
Type of Device
IN-VIVO INTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
ILLUMINOSS MEDICAL INC.
993 watterman ave
east providence RI 02914
Manufacturer (Section G)
ILLUMINOSS MEDICAL INC
993 waterman ave
east providence RI 02914
Manufacturer Contact
robert rabiner
993 waterman ave
east providence, RI 02914
4017140008
MDR Report Key8254310
MDR Text Key134585079
Report Number3006845464-2019-00002
Device Sequence Number1
Product Code QAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181228
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/30/2018
Device Catalogue NumberUSSL-1700260
Device Lot Number380423
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received01/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age59 YR
Patient Weight113
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