This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 260 patients (268 procedures) who underwent posterior instrumentation (c0-th1) procedures between june 7, 2005, to september 15, 2021.There were 147 males and 121 females with a mean age of 62.8 years.It was not specified in the spine tango registry report which of the devices mentioned have caused the adverse events.It was also not specified in which country the adverse events have occurred.Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: 7 patients had intraoperative general complications: - anaesthesiological (n=1) - other complications (n=2).24 patients had postoperative general complications: - cardiovascular (n=1) - pulmonary (n=7) - cerebral (n=2) - kidney / urinary (n=3) - liver / gi (n=1) - death (n=2) - other complications (n=5).7 patients had intraoperative surgical complications: - dural lesion (n=3) - vascular injury (n=2) - other complications (n=1).31 patients had postoperative surgical complications: - epidural hematoma (n=2) - other hematoma (n=2) - radiculopathy (n=1) - csf leak / pseudomeningocele (n=2) - motor dysfunction (n=6) - sensory dysfunction (n=3) - bowel / bladder dysfunction (n=2) - wound infection superficial (n=4) - wound infection deep (n=2) - implant malposition (n=1) - other complications (n=4).63 patients had a fair (n=52) and poor (n=11) outcome.35 patients had postoperative complications: - sensory dysfunction (n=6) - motor dysfunction (n=4) - non-union (n=4) - implant failure (n=4) - instability (n=2) - wound infection superficial (n=1) - extravertebral hematoma (n=2) - implant malposition (n=1) - recurrence of symptoms (n=2) - graft complication (n=2) - internal medicine (n=2) - adjacent segment pathology (n=1) - central nervous system (n=1) - other (n=3).25 patients had reoperations at any level due to: - adjacent segment pathology (n=1) - hardware removal (n=3) - implant failure (n=3) - instability (n=1) - neurocompression (n=2) - other reasons (n=4).3 patients had reoperations at same level due to: - hardware removal (n=2) - neurocompression (n=1) - other reasons (n=1).This report is for unknown depuy spine cervical i/f, mountaineer, brantigan cage, devex cage, harms cage, skyline plate, mountaineer occipital plate, and expedium.A copy of the clinical evaluation form is being submitted with this regulatory report.This is report 1 of 6 for pc-(b)(4).Additional reports are captured under pc-(b)(4).
|
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: there are multiple patients.All known information is provided in the literature article.510k: this report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a (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.
|