Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The contraindications in the ifu (instructions for use) states "patients with limited blood supply insufficient quantity or quality of bone, or latent infection." the user facility is foreign; therefore a facility medwatch report will not be available.The product was not returned by the hospital for an evaluation.Without a product return, no product evaluation is able to be conducted.It is stated that the surgeon did not blame the lactosorb screws but the bone quality of the patient.Based on this statement the cause of the complaint is determined to be patient condition.If additional information is obtained that adds value to the relevant content of this report and/or a different conclusion can be drawn, a follow-up report will be sent.This is report four of four for the same event.Reports one through three are reported on mfr #0001032347-2017-00163 through 0001032347-2017-00165.
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On a post-market survey for lactosorb distraction system, it was reported that the 1.5 mm screws are not working with the anatomical size of the pediatric patients.In some cases, the surgeon ends up suturing the product to the patient.Additionally, if the bone quality is not good, the lactosorb screws won't hold up.Specifically, it was stated that the surgeon had problems securing the distraction plate with screws.The surgeon's comment was that the patient had poor bone quality and the screws would not hold.The distraction plates were secured with pds (non-zimmer biomet product) sutures.The event created a delay of thirty to forty-five minutes to the procedure.It was added that the surgeon did not blame the lactosorb screws but the bone quality of the patient.
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