PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

AN EVENT WAS REPORTED INVOLVING FAILURE OF PRIOR FIXATION WITH THE ILLUMINOSS DEVICE, ASSOCIATED WITH A PATHOLOGIC FRACTURE OF THE RIGHT ILIUM DUE TO METASTATIC BREAST CANCER FOLLOWING RADIATION THERAPY. THE ORIGINAL ILLUMINOSS IMPLANT FROM THE (B)(6) 2024 PROCEDURE WAS LEFT IN THE PATIENT DURING THE SUBSEQUENT SURGERY.

Additional Manufacturer Narrative

THIS INVESTIGATION INTO THIS EVENT IS CURRENTLY ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD WITH A MEDICAL PROFESSIONAL. THE CASE INFORMATION AND X-RAYS WERE REVIEWED. MEDICAL REVIEWER STATED THAT DUE TO THE PATHOLOGICAL FRACTURE AND THE RADIATION WHICH WAS PERFORMED THE ABILITY OF THE BONE TO HEAL HAS BEEN REDUCED SIGNIFICANTLY. THE FACT THAT THE PATIENT REQUIRED A PLATE TO BE ADDED DURING THE REVISION SURGERY ALSO INDICATES THAT THE BONE QUALITY IS POOR. THE MEDICAL REVIEWER CONCLUDED THAT THE CAUSE OF THE REPORTED LOSS OF OR INADEQUATE FIXATION IN THE BONE AND THE NEW FRACTURE OF THE RIGHT ILIAC IS DUE TO THE SIGNIFICANT METASTATIC DISEASE THIS PATIENT HAS, THE POOR BONE QUALITY, AND COMPROMISED ABILITY OF THE BONE TO HEAL DUE TO THE RADIATION TREATMENT. THE MEDICAL REVIEWER STATED THAT THE REPORTED ADVERSE EVENT IS NOT RELATED TO THE ILLUMINOSS DEVICE OR PROCEDURE BUT IS CAUSED BY THE PATIENT'S PATHOPHYSIOLOGY. THE ILLUMINOSS IMPLANT FUNCTIONED PROPERLY, BUT THE PATIENT'S BONE WAS NOT ABLE TO HEAL DUE TO THE RADIATION TREATMENT AND METASTATIC DISEASE. THEY ALSO NOTED THAT A YEAR OUT AND THE PATIENT HAS REPORTED A 1 OUT OF 10 FOR PAIN IS A GOOD OUTCOME FOR THIS PATIENT. IFU REVIEW: THE ANATOMY TREATED IN THIS CASE WAS THE PELVIS WHICH IS ON LABEL USE IN THE US WHERE THE CASE OCCURRED. IFU 900356_X STATES THAT RISKS INCLUDE: LOOSENING, BENDING, CRACKING, FRACTURE, OR MECHANICAL FAILURE OF THE COMPONENTS OR LOSS OF OR INADEQUATE FIXATION IN BONE ATTRIBUTABLE TO DELAYED UNION, NONUNION, INSUFFICIENT QUANTITY OR QUALITY OF BONE, MARKEDLY UNSTABLE COMMINUTED FRACTURES, OR INSUFFICIENT INITIAL FIXATION, AND LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION SO THE RISK EXPERIENCED IN THIS CASE IS CAPTURED IN THE LABELING. POTENTIAL FOR USER ERROR: THERE IS NO INDICATION THAT USER ERROR OCCURRED IN THIS CASE. THE IMPLANT WAS PROPERLY IMPLANTED, AND THE MEDICAL OVERSIGHT REVIEW IDENTIFIED THAT THE CAUSE OF THE EVENT IS DUE TO THE PATIENT'S METASTATIC DISEASE, BONE QUALITY, AND COMPROMISED ABILITY OF BONE TO HEAL AFTER RADIATION, NOT DUE TO ANY USER ERROR. CONCLUSION: THE CAUSE OF THE REPORTED LOSS OF OR INADEQUATE FIXATION IN THE BONE AND THE NEW FRACTURE OF THE RIGHT ILIAC IS DUE TO THE SIGNIFICANT METASTATIC DISEASE THIS PATIENT HAS, THE POOR BONE QUALITY, AND COMPROMISED ABILITY OF THE BONE TO HEAL DUE TO THE RADIATION TREATMENT, AND IS NOT DUE TO THE ILLUMINOSS DEVICE OR PROCEDURE.

Description of Event or Problem

AN EVENT WAS REPORTED INVOLVING FAILURE OF PRIOR FIXATION WITH THE ILLUMINOSS DEVICE, ASSOCIATED WITH A PATHOLOGIC FRACTURE OF THE RIGHT ILIUM DUE TO METASTATIC BREAST CANCER FOLLOWING RADIATION THERAPY. THE ORIGINAL ILLUMINOSS IMPLANT FROM THE ON (B)(6) 2024 PROCEDURE WAS LEFT IN THE PATIENT DURING THE SUBSEQUENT SURGERY.