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

Catalog Number ML-09160

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

In (b)(6), a dementia patient was treated for broken fibula on (b)(6) 2020 with an illuminoss 9 x 160 implant.The treatment went well, and patient was given a vaccuped boot after surgery with instructions not to walk without it.The patient walked without the boot, twisted her foot, and the implant broke.Upon request, we received the update that the doctor treated the re-injury with an additional plate, using the illuminoss implant that remains implanted for fixation of that plate.The treatment went well.A review of the device history records (dhr) showed that this device met manufacturing specifications at the time of manufacture.Physical product evaluation could not be performed as device remains implanted in the patient.A review of the ifu found that as this procedure was for treatment of fibula fracture alignment reduction, the procedure is in line with approved indications for europe.However it was noted in the initial complaint report that this patient also suffers from dementia, which is contra-indicated for treatment with this product.The physician reported that use of a boot was prescribed to the patient after the illuminoss product was implanted, and that patient was non-compliant with these post-operative immobilization instructions, which led top patient twisting her foot, and breaking the implant.The patient's non-compliance may be attributable to her dementia, which would be a contraindicated use of this use of this product per ifu 900535 rev.B.Root cause: patient non-compliance with post-operative immobilization instructions, and possible user error, as this product is contra-indicated for a patient with neurologic disorder, incapable of following directions.A review of the fmea-1002 rev e identifies that this failure mode, effect, and cause are captured.No new failure modes, effects, or causes have been introduced by this complaint.Further analysis identified that the severity and occurrence of this risk are within the anticipated risk profile of the device per the fmea.No additional investigation activity is planned for this event.Root cause is identified, and product continues to perform within the anticipated risk profile of the device.Continue to track and trend this failure mode.No further action is required at this time.

Event Description

Dementia patient was treated in (b)(6) for broken fibula on (b)(6) 2020 [weber fracture- b].Treatment went well, and patient was given a vaccu-ped boot after surgery with instructions not to walk without it.Patient walked without the boot, twisted her foot, and broke the implant.The doctor later treated the re-injury with an additional plate, using the illuminoss implant that remains implanted for fixation of that plate.That the treatment went well.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman 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 Key: 11342301
• MDR Text Key: 232344083
• Report Number: 3006845464-2021-00002
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: ML-09160
• Device Lot Number: 400139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 72