Product complaint #: (b)(4).510k: this report is for an unk - constructs: plate/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 product was received; no conclusion could be drawn at the time of filing this report.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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This report is being filed after the review of the following journal article: hazewinkel, m.H.J.Et al (2020), complications and factors associated with reoperation following total wrist fusion, journal of wrist surgery vol.9 no.6, pages 1-11 (usa).This study aimed to investigate the overall complications and the factors associated with reoperation and soft tissue complication after total wrist fusion (twf).Between january 1, 2002 to january 1, 2019, a total of 215 patients underwent total wrist fusion for pain caused by osteoarthritis and rheumatoid arthritis.There were 118 males 97 females with a mean age was 53.3 +/ 15.0 years.Implants used were dcp, lc-dcp, lcp, spanning plate lcp.A dorsal fusion plate or dorsal spanning plate was used in all twfs, either with a local autograft (n = 167), iliac crest autograft (n = 2), allograft (n = 7), a combination of both (n = 16), or without a graft (n = 23).In most patients, a bent/angled plate (n = 177) with mostly 4 distal screws (n = 131) and 4 proximal screws (n = 139), was used.The median follow-up was 6.1 years.The article did not specify which of the devices were being used to capture the following complications: 12 patients had failed wrist arthroplasty.Reoperations: 41 patients underwent reoperation; 12 patients had symptomatic implants, 8 patients had implant failures, 2 patients underwent implant removal for broken screws, 1 patient underwent implant removal for broken and loose implant, 2 patients underwent implant removal for implant loosening, 1 patient had soft tissue incompetence with an exposed plate; this patient underwent implant removal and primary skin closure.Among the patients who had implant failure: 2 patients underwent implant removal with revision arthrodesis.The remaining 6 patients had the implant removed as the fusion was mature.7 patients had infections.2 patients underwent irrigation and debridement.2 patients underwent washout and vacuum-assisted closure.3 patients underwent implant removal alone.6 patients had nonunion (fig.2, 3).2 patients underwent implant removal and revision arthrodesis with a plate and local autograft.1 patient underwent implant removal and revision arthrodesis with a plate and allograft.1 patient underwent implant removal and revision with two radiocarpal screws and local autograft (fig.4 and 5).1 patient had nonunion of the scaphotrapezial and third cmc joint and had a revision with a plate, allograft, and local autograft with concomitant partial excision of the ulna.1 patient had nonunion but, based on their preference, underwent implant removal and pin neurectomy without arthrodesis.All revision arthrodesis achieved bony union.2 patients had ulnar impaction.1 patient had incorrect hardware size.1 patient had stress fracture.1 patient had adhesions of the tendons to the plate.1 patient had hardware removal without indication.1 patient had extensor tendon rupture.Soft tissue complications: 20 patients had soft tissue complications; 8 patients had hematomas, 5 patients observed blistering, 4 patients had wound dehiscence.Other complications: 72 patients had a postoperative complication and 28 patients had more than one complication resulting in a total of 100 postoperative complications.4 patients had symptomatic hardware, 3 patients had implant failure, 4 patients had infection, 2 patients had nonunion, 4 patients had carpal tunnel syndrome, 5 patients had finger stiffness, 10 patients had tenosynovitis, 2 patients had intrinsic contracture.This report is for an unknown synthes dcp, lc-dcp, lcp and spanning plate lcp.This report is for (1) unk - constructs: plate/screws.This report is 4 of 10 for (b)(4).
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