(2 of 4): the incident was received through manufacturer's legal department.No product has been returned, no lot number has been provided, no radiographs received and no further evaluation of the product can be completed at this time.The following medwatch numbers are all related to the same incident: 3012120772-2019-00018 ((b)(4)), 3012120772-2019-00020 ((b)(4)), 3012120772-2019-00021 ((b)(4)).It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's alleged disassociation.Review of labeling notes: possible adverse events: delayed union or nonunion (pseudarthrosis), bending, disassembly or fracture of implant and components, loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Labeling warnings and precautions: based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions.The root cause of this event cannot be determined at this time.No conclusion can be drawn.
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Index surgery occurred on (b)(6) 2017, which included a partial l4-5 decompressive lumbar laminectomy, left l5-s1 microforaminotomy, l4 to s1 pedicle instrumentation and facet fusion.According to the legal document received, bilateral set screws were broken, and rods were bent.It is unknown how the discovery of broken set screws and bent rods were identified, as no images or medical evaluation were provided.According to the legal document received, the patient sustained injuries which resulted in pain, requiring surgical intervention.Revision occurred on (b)(6)2018, which included removal of manufacturer's fixation system.Current patient condition is unknown.
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