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No product was returned, as it remains implanted in the patient.A review of the device history records (dhr) showed that this device met manufacturing specifications at the time of manufacture and release.Photos and radiographs of the initial implantation and of the patient before and after revision surgery were provided by the user.A review was conducted with illuminoss engineering, clinical affairs, and medical oversight reviewer.We found the following: we can verify that the initial facture that was treated was a complete fracture.Review of the images provided shows the lesion that was treated, and it is an extensive one.The implant appears to have been appropriately deployed, as noted by examining the images provided that show the intramedullary canal fill is good proxmially and distally, in that there is not evidence of lack of contact with the corticle wall.The implant was well positioned across the fracture site.The bone treated appears to have an appropriate diameter at the fracture site per the ifu for this product (>13mm), appearing to be greater than 13mm.As such, the implant's diameter would have provided strength sufficient to support the bone.The team notes the doctor's comment that after the initial implant surgery, the implant was "satisfactory and very stable".This review team observed that the break observed in the radiographs collected on (b)(6) 2021 (2 weeks post implant) would be the result of the application of a high energy impact.A review of the illuminoss validation testing and verification reports supports this interpretation, that an implant placed according to the ifu will provide stabilization and fixation in this anatomy.Follow up communication with the complainant regarding further information about patient compliance to post-operative instructions revealed that the answer to this line of inquiry cannot be established.The complainant reported that this patient suffers from cognitive impairment due to severe metastases of the brain, and therefore is not able to talk anymore.The patient was unable to communicate to the doctor when the pain (post-implant) had started, and whether there was any traumatic event (like a fall) that had occurred at that time.The hospital further investigated and found that between the date of implant and the date of discovery via xray that the implant had broken, this patient had been moved first to a sister hospital in brul, and then to the hospital in baden-baden, which constitutes a lot of movement and potential for introducing impact to the patient.The doctor stated that a fall cannot be ruled out.Root cause analysis tool: the analysis tool used for root cause analysis of this complaint was rule in / rule out.Following this process, potential causes were confirmed as ruled out, and a potential cause was identified as the probable cause, although it remains unconfirmed.Confirmed: (b)(6).Unconfirmed: implant break caused by external trauma is a possible cause, that fits the observable facts, and cannot be ruled out.Patient not compliant with standard care recommendations provided by the surgeon is a possible cause, that cannot be ruled out.Complaint investigation results: a review of manufacturing records found that the device met specifications at the time of manufacture and release.A review of the patient's pre- and post-implant break x-rays allowed the investigation team to rule out a number of potential root causes for the implant break, including off-label use, and implant placement technique related causes.These are listed above in the root cause analysis tool section.The review of the x-rays, along with the additional information provided by the treating physician related to the patient's condition and the known patient movements between the date of the implant and the date of discovery of the implant break suggests two potential root causes.The patient not adhering to the surgeon's recommendation relative to the care of their arm during the healing process, and the potential that the patient may have experienced some external force in the area of the fracture which caused the implant to break.Due to the patient's inability to speak or communicate, both of these probable root causes remain unconfirmed.The opinion of the treating physician was that the cause of the implant break was potentially a "patient fall", which correlates to the probable cause identified here of patient accident causing excess stress on the implant at the fracture site.Conclusion: complaint investigation allowed us to rule out many potential causes and narrow down the probable cause of the implant break to two potential causes related to patient conformance, and additional trauma experienced by the patient.When these investigation results are combined with the opinion of the treating physician, the most likely cause of this implant break was patient accident causing excess stress on the implant at the fracture site.
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A patient was treated by dr.(b)(6) in (b)(6) with an illuminoss photodynamic bone stabilization implant on (b)(6) 2021 for a pathologic humerus fracture after metastasis in the left upper arm.Immediately after implantation, the doctor described the stabilized bone as satisfactory and very stable.While being treated for other ailments, the patient was transferred on (b)(6) 2021 first to the sister hospital in brühl, and then to the hospital in baden-baden where the patient indicated severe pain in the left upper arm, and a fracture of the implant was detected via x-ray.The treating physician reported that this patient suffers from cognitive impairment due to severe metastases of the brain, and therefore is not able to talk anymore.The patient was unable to communicate to the doctor when the pain (post-implant) had started, and whether there was any traumatic event (like a fall) that had occurred at that time.The doctor stated that a fall cannot be ruled out.
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