Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - mono/polyaxial screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: yeh, k.T.Et al (2020), two surgical strategies for treating multilevel cervical spondylotic myelopathy combined with kyphotic deformity, medicine, vol.99 (7; e19215), pages 1-7 (taiwan).The aim of this retrospective study is to present the surgical results of the two different operation strategies for patients who were diagnosed as having mcsm combined with ckd.Between january 2013 to december 2017, a total of 105 patients (54 male and 51 female) with a mean age of 64.5±11.9 years were included in the study.Of these, 63 patients underwent elta, and 42 patients underwent lapi.The elta method involved c3-6 eolp secured with miniplates (synthes, mi) and a c7 partial laminectomy followed by c3-6 or c4-7 acdfs with titanium cages.The lapi method involved applying acdfs (>3 segments) with polyetheretherketone (peek) cages, c2-7 or c3-7 pif with lateral mass or a pedicle screw-rod system (synthes spine, westchester, pa), and pd through laminoplasty secured by miniplates (synthes, mi).The minimum follow-up period was 1 year.The following complications were reported: an unknown number of patients had loss of correction at postoperative year 1 was <5° in both groups.All 105 patients had mild to moderate dysphagia 2 weeks post-surgery, which persisted in 35 (33.3%) patients 2 to 6 weeks post-surgery: 25 of such patients were in the elta group (39.7%) and 10 were in the lapi group (23.8%).7 patients had poor posterior side wound healing and required surgical debridement and repair: 4 were in the elta group (6.3%) and the 3 were in the lapi group (7.1%).This report is for an unknown synthes laminoplasty miniplates/screws constructs, unknown synthes mono/polyaxial screws, and unknown synthes rods.A copy of the literature article is being submitted with this medwatch.This report is for (1)unk - mono/polyaxial screws.This report is 2 of 3 for (b)(4).
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