3 of 5 reports (same event, same patient, different products) other mfg report numbers: 9615741-2020-00013, 9615741-2020-00014, 9615741-2020-00016, 9615741-2020-00017.A facility reported that on (b)(6) 2019 the patient had an arthrodesis procedure and after 9 months it became into pseudoarthrosis.The surgeon thinks that he might given a longer cast period to immobilize the foot.Revision was performed and was replaced with another plate system.It was reported the x-rays showed that the implant did not failed.Additional information has been requested.
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Device identifier: (b)(4).Results of the documentary investigation does not reveal any issue about the design, the manufacturing or the inspection of concerned product lots.Investigation for cause cannot be performed as the product is unavailable.Regarding clinical review, the patient conditions (smoker) and / or the post-surgical treatment (that was not fully compliant with non-weight bearing instruction) can be found as root cause of the incident.
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