This report is for an unknown veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is article author.No other information available.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: lagrea, j., flynn, t.And garg, s.(2015), utility of intraoperative neurologic monitoring during veptr expansion surgery, journal of investigative medicine vol 63(1), page 153 (usa).The purpose of this study was to investigate whether, in the absence of intraoperative neurologic signal changes during initial veptr implantation, intraoperative neurologic monitoring will identify new neurologic injuries with routine expansion procedures.A total of 525 consecutive unknown synthes vertical expandable prosthetic titanium rib (veptr) procedures were reviewed among 216 patients: 157 implants, 87 revisions, 251 expansions and 30 removal procedures.Additional retrospective evaluation was undertaken in cases of intraoperative neurologic monitoring (ionm) signal change or neurologic injury.The following complications were reported as follows: new neurologic injury occured in 4 patients or 4 procedures.3 of the neurologic injuries were associated with implant procedures and 1 was associated with a revision procedure.All neurologic injuries had full postoperative recovery within 33 days on average.This is report 1 of 1 for (b)(4).This is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).
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