PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY FOR A LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT NON-SURGICAL INTERVENTION (STEROID INJECTION AND BONE STIMULATION) TO ADDRESS THE NONUNION/MALUNION. THE COMPLAINT INVESTIGATION IS ONGOING AND A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY FOR A LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT NON-SURGICAL INTERVENTION TO ADDRESS THE NONUNION/MALUNION. THE COMPLAINT INVESTIGATION IS ONGOING AT THIS TIME AND A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

EVENT DESCRIPTION: AN ADVERSE EVENT WAS RECEIVED FOR A LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT NON-SURGICAL INTERVENTION TO ADDRESS THE NONUNION/MALUNION. ROOT CAUSE INVESTIGATION. MEDICAL OVERSIGHT REVIEW MEETING: A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD; THE X-RAYS AND CASE INFORMATION WERE REVIEWED. MEDICAL OVERSIGHT NOTED THAT THE ADVERSE EVENT SUBMITTED STATED "LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION" BUT HE DOES NOT SEE ANY LOSS OF ANATOMIC POSITION. MEDICAL OVERSIGHT DID STATE THIS IS ONLY A PARTIAL (OR INCOMPLETE) UNION, BUT IF IT WAS A FULL NONUNION, HE WOULD HAVE EXPECTED THIS CONSTRUCT TO HAVE COMPLETELY FALLEN APART AT THE 10 MONTH FOLLOW UP X-RAYS, WHICH IT HAS NOT. THIS DEMONSTRATES THAT THE FRACTURE MUST HAVE HEALED ENOUGH TO KEEP THIS CONSTRUCT TOGETHER. MEDICAL OVERSIGHT OBSERVED AT THE BASE OF THE FRACTURE THERE IS A SLIGHT GAP, WHICH MAY HAVE CONTRIBUTED TO THE PARTIAL NON-UNION. A CT ON THIS PATIENT WOULD MOST LIKELY SHOW THE FRACTURE IS PARTIALLY HEALED. MEDICAL OVERSIGHT ALSO STATED THAT HE IS NOT SURPRISED THE PATIENT IS HAVING PAIN WHEN HE RAISES HIS ARM. HE OBSERVED THE PATIENT'S PROXIMAL HUMERUS HAS A SLIGHT VARUS (SLIGHT INWARD MEDIAL ANGULATION OF THE HUMERAL HEAD RELATIVE TO THE SHAFT) AND THERE IS A PLATE PRESENT, SO IT IS LIKELY THAT WHEN THE PATIENT RAISES HIS ARM THERE IS SLIGHT PINCHING OF THE GREATER TUBEROSITY DUE TO THE PLATE WHICH CAUSES PAIN. THERE MAY HAVE ALSO BEEN A ROTATOR CUFF INJURY DURING THE INDEX PROCEDURE THAT IS ALSO CONTRIBUTING TO THE PAIN EXPERIENCED WHEN THE PATIENT RAISES THEIR ARM. MEDICAL OVERSIGHT STATED THAT THE ILLUMINOSS IMPLANT IS NOT CAUSING THE PAIN EXPERIENCED BY THE PATIENT. HE ALSO OBSERVED THE ILLUMINOSS APPEARS PROPERLY DEPLOYED AND HAS NOT MOVED FROM ITS ORIGINAL IMPLANT POSITION AND THE SCREWS WHICH HAVE PURCHASE INTO THE ILLUMINOSS HAVE ALSO NOT MOVED. THEREFORE, THE ILLUMINOSS AS FUNCTIONED PROPERLY AS A FRACTURE STABILIZATION CONSTRUCT, AND A PARTIAL UNION OCCURRED BECAUSE THERE WAS NOT COMPLETE HEALING OF THE FRACTURE. THE CAUSE OF THE INCOMPLETE HEALING IS UNKNOWN BUT COULD POTENTIALLY BE CONTRIBUTED TO THE SLIGHT GAP AT THE FRACTURE SITE OR THE PATHOPHYSIOLOGY OF THE PATIENT'S BONE, BUT THERE IS NO INDICATION THE NON-UNION WAS CAUSED OR CONTRIBUTED TO BY THE ILLUMINOSS DEVICE, AS IT FUNCTIONED PROPERLY TO STABILIZE THE FRACTURE AND ALLOW HEALING. DHR REVIEW: THE DHR FOR THE IMPLANT USED WAS REVIEWED AND FOUND IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THERE IS NO INDICATION THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. RETURNED PRODUCT EVALUATION: N/A PRODUCT REMAINS IMPLANTED. IFU REVIEW AND POTENTIAL FOR USER ERROR: THE DEVICE WAS USED ACCORDING TO THE INDICATIONS FOR USE AND INSTRUCTIONS FOR USE PER 900356_X. THERE IS NO INDICATION THAT ANY USE ERRORS OCCURRED, OR THAT ANY USE ERRORS CONTRIBUTED TO THIS COMPLAINT. RISKS IN IFU 900356_X INCLUDE: "AS WITH ANY IM FIXATION SYSTEM OR ROD THE FOLLOWING CAN OCCUR: · 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 · LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION." THE RISK OF PARTIAL NONUNION IS CAPTURED IN THE IFU. CONCLUSION: THE FAILURE IN THE COMPLAINT WAS REPORTED AS "LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION" HOWEVER THE MEDICAL OVERSIGHT REVIEW DID NOT IDENTIFY ANY LOSS OF ANATOMIC POSITION, AND OBSERVED THIS IS ONLY A PARTIAL NONUNION, BECAUSE IF THIS WAS A FULL NONUNION THE CONSTRUCT WOULD HAVE FALLEN APART BY 10 MONTHS POST OP., WHICH IT DID NOT. THE MEDICAL OVERSIGHT REVIEW IDENTIFIED THAT THE ILLUMINOSS DEVICE WAS PROPERLY DEPLOYED, REMAINS IN THE SAME ANATOMIC POSITION AS WHEN IT WAS IMPLANTED, AND STABILIZED THE FRACTURE. THE MEDICAL OVERSIGHT REVIEW ALSO IDENTIFIED OTHER POSSIBLE CAUSES OF THE PATIENT'S PAIN, NOT ATTRIBUTABLE TO THE ILLUMINOSS DEVICE (PINCHING OF THE GREATER TUBEROSITY WHEN THE PATIENT RAISES THEIR ARM DUE TO THE PLATE, AND POSSIBLE ROTATOR CUFF INJURY DURING INDEX PROCEDURE). THE SINGULAR CAUSE OF THE PARTIAL UNION IN THIS CASE WAS UNABLE TO BE DETERMINED. POTENTIAL CONTRIBUTING FACTORS INCLUDE THE SLIGHT GAP AT THE FRACTURE SITE, OR THE PATHOPHYSIOLOGY OF THE BONE, BUT THERE IS NO INDICATION THAT THE ILLUMINOSS DEVICE CONTRIBUTED TO THE NONUNION AS IT PROPERLY STABILIZED THE FRACTURE AND PARTIAL HEALING OCCURRED (A PARTIAL UNION).

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY FOR A LOSS OF ANATOMIC POSITION WITH NONUNION OR MALUNION WITH ROTATION OR ANGULATION. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT NON-SURGICAL INTERVENTION TO ADDRESS THE NONUNION/MALUNION.