There are multiple patients all information is provided in the article.This report is for an unknown peek implant/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2000 and (b)(6) 2016.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.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.
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This report is being filed after the review of the following journal article: binhammer, a.Et al.(2020), comparative cost-effectiveness of cranioplasty implants, plastic surgery, vol.28(1), pages 29-39 (canada) the aim of this study was to compare operative duration and total hospital costs incurred for patients undergoing elective cranioplasty with a variety of materials, including manually shaped autogenous bone graft and titanium mesh, custom patient-specific titanium mesh, polymethyl methacrylate (pmma) acrylic, and polyetheretherketone (peek) implants.Between january 2000 and july 2016, a total of 119 patients underwent elective cranial vault reconstruction with autologous split skull bone graft, manually shaped or custom patient-specific titanium implants, pmma, or peek.11 patients had custom peek implants (depuy synthes, raynham, massachusetts).There were 6 males and 5 females for peek implant patients.The following complications were reported as follows: 5 patients had complications of which 3 required surgical intervention 1 patient had poor contour.1 patient had implant exposure.1 patient had infection.This report is for an unknown synthes peek a copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown peek implant.This is report 2 of 3 for (b)(4).
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