18. In each of the cases below the patient has described severe pain to their surgeon. In these cases the devices were x-rayed and in some instances retrieved. You are the research engineer at a failure analysis company specializing in medical implants. You must analyze the following devices. For each case: (i) Identify the implant. List the biomaterials used in the pictured implant. (ii) Describe the failure mode. (iii) Is this likely to be a manufacturing flaw, surgical error, overload to the implant, or failure due to normal use? (iv) Make a recommendation as to how this failure could have been prevented.
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2. Silicone implant augmentation rhinoplasty is used to correct congenital nose deformities. The success of the procedure depends on various biomechanical properties of the human nasal periosteum and fascia. The article "Biomechanics in Augmentation Rhinoplasty" (J. of Med. Engr. and Tech., 2005: 14–17) reported that for a sample of 15 (newly deceased) adults, the mean failure strain (%) was 25, and the standard deviation was 3.5. a. Assuming a normal distribution for failure strain, estimate true average strain in a way that conveys information about precision and reliability. Interpret the Confidence Interval. b. Predict the strain for a single adult in a way that conveys information about precision and reliability. How does the prediction interval compare to the interval calculated in part (a)? Interpret the result.
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PROCEDURES PERFORMED: 1. Bilateral facet joint injections, L4-L5. 2. Bilateral facet joint injections, L5-S1. 3. Fluoroscopy. TECHNIQUE: The AP view was aligned with the proper tilt so that the end plates for the desired levels were perpendicular. The AP image showed the sacrum and the L5 spinous process. Manual palpation located the sacral hiatus. The 6-inch, 20-gauge needle with a slight volar bend was inserted using fluoroscopy into each facet joint under AP image. The bilateral L4-L5 and L5-S1 facet joints were injected in a systematic fashion from caudal to cranial. A sterile dressing was applied. The patient tolerated the procedure well with no complications and was transferred to recovery in good condition.
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