Multiple attempts to gather additional information surrounding the events have been made; however, it is unknown if surgical intervention was required or is planned.There were no reported issues with surgical technique and it is unknown if the patient complied with post-operative warnings, all of which can contribute to post-operative failures.The product was not returned for investigation.Additionally, the part number and lot number were not provided.The x-ray provided does confirm the spacer has prematurely separated from the spine; however, a root cause was unable to be determined due to insufficient information.Possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or non-union (pseudarthrosis).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.
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It was reported to seaspine on (b)(6) 2021 that the seaspine spinous process system failed in five patients in the postoperative period.Please reference the following five reports to capture the 5 patients/ events: 3012120772-2021-00092, 3012120772-2021-00094, 3012120772-2021-00095, 3012120772-2021-00096.
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