|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown unk - constructs: 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.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.
|
|
Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: man-ger sun m., et al (2022).No difference in the rates of unplanned return to the operating room between magnetically controlled growing rods and traditional growth friendly surgery for children with cerebral palsy, j pediatr orthop _ volume 42, number 2, pages 1-9 (canada).This prospective study aims to examine the frequency of unplanned return to the operating room (uprors) between magnetically controlled growing rods (mcgr) as compared with traditional growth-friendly (tgf) surgeries for children with early onset scoliosis (eos) secondary to cerebral palsy (cp).Study participants included pediatric patients under the age of 10 (below 10.0 y) with early onset scoliosis (eos) secondary to cerebral palsy (cp) that have undergone growth-friendly surgery with a minimum of 2-year follow-up.Of the 120 patients that met inclusion criteria, the majority [86 patients] were classified as gross motor function classification system (gmfcs) level v, and 23 patients had unreported gmfcs classification.The mean age at the time of surgery for the entire cohort was 7.2±2.1 years, and gender composition was 53 males and 67 females.Eighty-six patients received tgf surgery (mean age 7.5 ± 1.8 y; final follow-up 7.0 ± 2.9 y) and 34 received mcgr (mean age 7.1 ± 2.2 y, final follow-up 2.8 ±0.5 y).Within the tgf group, 52 received tgr, and 34 (40%) received veptr.The mean final follow-up period was 5.8±3.1 years for the entire cohort.Reported complications: the percentage of patients in each group who had undergone definitive fusion at time of final follow-up is as follows: 4 of 86 patients who received tgf (1 of 34 only for veptr).Compared with tgf, mcgr resulted in significant improvements in maintenance of primary curve correction (64±26 degrees tgf, 48±18 degreesmcgr; p=0.007) at final follow-up.When tgr and veptr were examined separately, mcgr¿s maintenance of primary curve correction was superior to veptr (72±24 degrees veptr, 48±18 degrees mcgr; p=0.003) but comparable to tgr (58±26 degrees veptr, 48±18 degrees mcgr; p=0.34) table 2.Patients treated with mcgr had superior maintenance of percent curve correction (postoperative-final correction) compared with tgf (-54%±84% tgf, 0%±26% mcgr; p=0.002), and when compared with tgr (-49%±88% tgr, 0%±26% mcgr; p=0.03) and veptr separately (-62%±78% veptr, 0%±26% mcgr; p=0.005) table 3.Significant recurrence of primary coronal curve scoliosis at final follow-up in veptr-treated patients, where curve magnitude at final follow-up was observed to be comparable to the preoperative curve magnitude (72 vs.80 degrees, respectively).Mean maximum kyphosis patients treated with veptr, mean t1-s1 height postoperative : 31.1 (5.1 cm) and follow-up: 32.2 (4.2 cm) and mean t1-t12 height postoperative : 19.2 (3.4 cm) and follow-up: 19.6 (3.4).At final follow-up, unplanned return to the operating room (uprors) occurred 37 of 86 patients for tgf.Seventy-six of 87 total complications leading to uprors occurred in tgf treated patients, of which 34 complications were in veptr-treated patients.Within the first 2 years postoperatively, 47 of 57 total complications leading to unplanned return to the operating room (uprors) occurred in tgf-treated patients, of which 22 complications were in veptr treated patients.Thirty-eight of the tgf-related complications were classified svii (36 sviia where a single unplanned surgery was required, 2 sviib where multiple unplanned surgeries were required), 9 classified sviii where growth friendly treatment was permanently abandoned.Etiology of unplanned return to the operating room (uprors) in tgf-treated patients (veptr): for final follow-up (minimum 2 y): 6 deep infection, 7 implant failure/migration, 7 dehiscence, 3 superficial infection, 5 other.Within 2 y follow-up: 4 deep infection, 5 implant failure/migration, 3 dehiscence, 1 superficial infection, 4 other.This report is for unknown synthes veptr.This is report 2 of 2 for (b)(4).
|
