This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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.(b)(4).
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This report is being filed after the review of the following journal article: greiner-perth, r.Et al.(2004), reoperation rate after instrumented posterior lumbar interbody fusion: a report on 1680 cases, spine, vol.29, number 22, pages 2516-2520 (germany).The aim of the present study is to analyze the reoperation rate after the use of a single plif concept.Between january 1995 and december 2000, a total of 1,680 patients (952 males and 728 females) with a mean age of 53 years underwent a plif using moss and moss-miami (depuy acromed, raynham, ma) and 2 harms titanium mesh (16-mm diameter, depuy acromed).The following complications were reported as follows: 5 patients died.76 patients had reoperations due to psuedoarthrosis.48 patients had reoperations due to stability of adjacent segment.27 had reoperations due to re-decompression.26 had reoperations due to wound healing problems.4 patients had reoperations due to postoperative bleeding.2 patients had reoperations due to spondylitis.5 patients had nerve root injury, but this was in the form of neuropraxia that recovered after surgery.1 patient had cauda equina injury.55 patients had dural violation with cerebrospinal fluid leak.20 patients had reoperations due to implant failure.Screw or rod breakage without preoperative and intraoperative evidence of a pseudarthrosis resulted in 20 reoperations for implant removal.17 patients had reoperations due to screw misplacement.This report is for a moss and moss-miami (depuy acromed, raynham, ma) and 2 harms titanium mesh (16-mm diameter, depuy acromed).This report is for unknown screw/rod construct accessorie.It captures the reported reoperations, psuedoarthrosis, stability of adjacent segment, re-decompression, wound healing problems, postoperative bleeding, spondylitis, nerve root injury, cauda equina injury, dural violation with cerebrospinal fluid leak.This is report 1 of 4 for complaint (b)(4).
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