A review of the device history record, manufacturing records, sterility records, incoming inspection of raw material components, in-process and final inspection process.No non-conformities were identified.No changes were made to the formulation, processes or packaging.The product is sold to cardinal health as a sterile product, bulk device.No photos were provided of the surgical site or of the device used.No sterile devices from lot aaeg160, aagf768 were returned for testing/review.According to ifu p/n: 03-5125 r5 for bone wax 903b: under ¿directions and dosage¿ section: use bone wax immediately after removal from the package.Using aseptic technique, take 1 to 1.5 grams of bone wax, manipulate with the fingers to soften, and apply to bone surface.Optimum working temperature 70°- 74° f ( 21°- 23°c).Under ¿storage¿ section: recommended storage conditions: below 77° f (25 °c), away from moisture and direct heat.Samples from a different lot reported for a similar adverse case ((b)(4)) were received from the same facility for review/testing.The sterile samples were manipulated per the instructions in the ifu.The wax became warm, malleable and easily adhered to a hard surface.The wax device was similar to putty, no signs of flakes or crumbling was observed.Without receiving additional details regarding the patient's health history, procedure performed, method utilized to manipulate and utilize the bone wax and/or the surgeon's technique, a definitive root cause cannot be determined at this time.
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Patient had initial surgery (b)(6) 2020 where bone wax ( from cardinal health craniotomy pack) was used to repair the csf leak.Patient came back for surgery on (b)(6) 2021 to repair csf leak with the bone wax; patient again return to or on (b)(6) 2021 to repair the csf leak with bone wax from a different manufacturer.The bone wax was identified as being flaky, brittle, and did not provide an adequate seal.Bone wax used during surgery on (b)(6) 2021: surgical specialties bone wax, ref 903, lot#aagf768.Bone wax used during surgery on (b)(6) 2020: surgical specialties bone wax, ref 903, lot# aaeg160.
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