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Patient identifier, date of birth, and weight not available for reporting.Date of event: unknown.This report is for an unknown veptr implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant/explant is not known.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 subsequent review of the following literature article: lagreca (2017) patients without intraoperative neuromonitoring (ionm) alerts during veptr implantation did not sustain neurological injury during subsequent routine expansions: a retrospective (b)(6) study.Journal of pediatric orthopaedics.Volume 37(8), pages e619-e624.United states the aim of this study was to determine the rate of intraoperative neurological monitoring (ionm) alerts and neurological injury during vertical expandable prosthetic titanium rib (veptr) treatment and evaluate the utility of ionm during veptr expansion procedures in patients who have not previously had neurological injury or ionm alerts.The primary outcome variable was postoperative neurological injury, defined as a new loss of sensory or motor function identified during postoperative neurological examination.A secondary outcome variable of interest was the presence of significant ionm signal change during veptr surgery.A significant change in somato sensory evoked potential (ssep) monitoring was defined as, a >50% decrease in amplitude and/or a >10% increase in latency of the subcortical and/or cortical waveforms, whereas a significant change in motor-evoked potential (mep) monitoring was defined as a complete loss of waveforms.There were 4 types of surgical procedures: (1) implant, defined as the index procedure at which the veptr construct was placed, (2) revision, a procedure to replace or compensate for a failed implant or undesirable sequelae of previous surgery, (3) expansion, routine lengthening of the device to maintain correction of the deformity as the patient grows, and (4) removal, the explantation of veptr implants when the patient has attained skeletal maturity and is ready to proceed to definitive spinal fusion, or explantation secondary to intolerable sequelae.Data were collected for all consecutive patients surgically treated with primary veptr device implantation from 2005 to 2011.All patients had minimum 2 years of continued clinical follow-up.There were a total of 2355 consecutive veptr procedures (in 352 patients) consisting of 299 implants.The following complications were recorded: there were 377 revision surgeries needed.There were 1587 expansion surgeries needed.There were 92 implant removal surgeries needed.Six-hundred twenty (620) veptr procedures had reported the use of intraoperative neurological monitoring (ionm).Two-hundred fifty-six (256) patients had ionm performed during the course of their veptr treatment.The ionm alerts occurred in 9/539 procedures.Four of these alerts consisted of significant changes in ssep waveforms, 3 consisted of complete loss of mep waveforms and 2 had both significant changes and loss of ssep and mep waveforms.The ionm alerts occurred in 7/352 patients, with 1 patient having alerts in 3 procedures patient (a) - (b)(6) female diagnosed with congenital scoliosis with fused ribs secondary to klippel-feil syndrome had preoperative coronal deformity of 80 degrees and sagittal deformity of 35 degrees.Patient experienced neurological injury that was implant related.Patient was.Mep were attempted, but not obtainable for this patient; ssep were obtained and monitored for the surgical procedure.The patient had an ionm alert during implant procedure, which occurred during device distraction¿ and was interpreted as a brachial plexus compression.The device was removed from its attachment sites at the second and seventh ribs with subsequent recovery of the ssep waveforms, recontoured, and reapplied with less distraction.At completion of the case the ssep waveforms were at their baseline values.Throughout the postoperative follow-up the patient did not have any sensory changes.The patient had intact motor function on postoperative evaluation, but subsequently developed partial brachial plexus palsy with upper extremity weakness during the second postoperative week.The treating team presumed this neurological change to be due to surgical edema.The patient underwent physical rehabilitation and had full recovery at 124 days after presentation of the injury.Patient had a significant reduction of ssep waveforms during distraction of the rod and presumed compression of the brachial plexus; the device was subsequently removed until waveforms returned, at which point the rod was recontoured and applied with less distraction.This was the only patient to present with neurological injury following an ionm alert patient (b) - (b)(6) male diagnosed with congenital scoliosis with fused ribs and thoracic insufficiency syndrome secondary to vater syndrome had preoperative coronal deformity of 32 degrees and sagittal deformity of 33 degrees.Patient experienced neurological injury that was implant related.This patient underwent veptr device implantation without ionm alert and had a normal initial postoperative evaluation, but on the sixth postoperative day presented with upper extremity sensory and motor deficits.The patient completed physical rehabilitation and had full recovery at 30 days after the reported injury.Patient (c) - (b)(6) female diagnosed with congenital scoliosis with fused ribs had coronal deformity of 62 degrees and a sagittal deformity of 50 degrees.Patient experienced neurological injury that was implant related.The patient was without ionm alert during implantation and had upper extremity motor weakness on postoperative examination that was reported to be recovering.One day after the procedure the rate of recovery was determined to be inadequate; the treating surgeon attributed the neurological injury to over distraction of the veptr device leading to elevation of the first rib and compression of the brachial plexus.The patient was subsequently taken back to the operating room to have the device removed.Two weeks later the patient returned to the operating room for the third time, and the device was successfully re-implanted.The patient had an uneventful postoperative period with full recovery 17 days after the injury.Patient (d) - (b)(6) female diagnosed with syndromic scoliosis (chromosomal abnormality had preoperative coronal deformity of 103 degrees and sagittal deformity of 80 degrees.The patient had an ionm alert in bilateral upper extremity during implant procedure.The alert was related to > 50 % ssep signal loss.This alert was determined not to represent any evident complication and no intervention was pursued by the surgeon.However, a significant reduction of patient¿s ssep signals occurred during closure¿well after any manipulation or correction of the spine¿and resolved spontaneously patient (e) - (b)(6) male diagnosed with infantile idiopathic scoliosis had preoperative coronal deformity of 70 degrees and sagittal deformity of 76 degrees.The patient had an ionm alert in lower extremity during implant procedure.The alert was related to > 50 % ssep signal loss.This alert was determined not to represent any evident complication and no intervention was pursued by the surgeon these significantly reduced ssep signals remained stable throughout the procedure.Patient (f) - (b)(6) female diagnosed with congenital scoliosis (chromosome deletion) had preoperative coronal deformity of 88 degrees and sagittal deformity of 56 degrees.The patient had an ionm alert in bilateral upper extremity and lower extremity during revision procedure.Patient had ssep and mep alerts before incision, ssep loss (>50%) and mep loss.The patient was repositioned; however, a full recovery of ssep and mep waveforms did not occur and the veptr procedure was canceled.At age 7, the patient had an ionm alert in bilateral upper extremity and lower extremity during expansion procedure.The alert was related to mep signal loss an mri was ordered and revealed stenosis of the foramen magnum, the patient subsequently underwent suboccipital decompression.An uneventful veptr procedure was later performed.However, the patient¿s stenosis reoccurred and resulted in ssep and mep alerts and cancellation of 2 subsequent veptr procedures.At age 8 year, the patient had an ionm alert in bilateral upper extremity and lower extremity during expansion procedure.The alert was related to ssep loss (>50%) and mep loss.Patient¿s stenosis reoccurred and resulted in ssep and mep alerts and cancellation of 2 subsequent veptr procedures.Patient (g) - (b)(6) male diagnosed with syndromic scoliosis (townes brock syndrome) had coronal deformity of 71 degrees and sagittal deformity of 77 degrees.Patient had no prior history of ionm alerts presented for excision and drainage of veptr hardware and then underwent veptr expansion.The patient had an ionm alert, ssep loss (>50%) in lower extremity during revision procedure.This patient developed decreased ssep waveforms during tightening of the veptr device and closure.The patient¿s blood pressures were noted to be low at this time and fluids were administered.The patient¿s blood pressure increased and the ssep waveforms returned to baseline.Patient (h) - (b)(6) female diagnosed with congenital scoliosis with fused ribs had coronal deformity of 32 degrees and sagittal deformity of 29 degrees.The patient had an ionm alert, mep loss in lower extremity during revision procedure.Patients had loss of mep waveforms after placement of the veptr device, the waveforms returned after surgeons repositioned the patient.Patient (i) - (b)(6) male diagnosed with neuromuscular scoliosis (unknown myopathy) had coronal deformity of 68 degrees and sagittal deformity of 39 degrees.The patient had an ionm alert, mep loss in lower extremity during revision procedure.Patients had loss of mep waveforms after placement of the veptr device, the waveforms returned after surgeons decreased the distraction of the rod.This report is for patient a with neurological complication.This is report 2 of 10 for (b)(4).
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