MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER 2; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Nerve Damage (1979); Pain (1994); Numbness (2415); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
|
Event Type
Injury
|
Event Description
|
This report is being filed after the review of the following journal article: lv h, et al.(2023), simultaneous single-position lateral lumbar interbody fusion surgery and unilateral percutaneous pedicle screw fixation for spondylolisthesis, neurospine ;20(3):824-834.(china) the objective of this study was to evaluate the clinical and radiological efficacy of a combine of lateral single screw-rod and unilateral percutaneous pedicle screw fixation (lsup) for lateral lumbar interbody fusion (llif) in the treatment of spondylolisthesis.Between (b)(6) 2021 to (b)(6) 2022, 62 patients with lumbar spondylolisthesis who underwent minimally invasive (mis)-tlif with bilateral pedicle screw (bps) or llif-lsup were included in the study.Of these, 26 patients (11 males, 15 females, mean age 62.2±8.8 years) underwent llif-lsup and 36 patients (15 males, 21 females, mean age 60.6±9.6 years) underwent mis-tlif-bps.For both extreme lateral lumbar interbody fusion and oblique lateral lumbar interbody fusion procedures, the unknown depuy spine viper 2 system percutaneous pedicle screws and connecting rods were used.For the patients in the llif-lsup group, spondylolisthesis reduction, screws, cage, and connecting rod insertion were performed simultaneously.An unknown synthes oracle cage filled with a competitor allogeneic bone grafts (manufacturer: dastingbio-tech co) was used.Meanwhile, for the patients in the mis-tlif-bps group, routine endplate preparation, allogeneic bone grafting and cage placement were performed in sequence.A competitor¿s cage (manufacturer: zimmer) was used.Postoperatively, all patients were required to wear a rigid brace at all times when they were up, for 3 months following surgery.Follow-up time points were 3, 6, 9, 12 months postoperatively, respectively.Complications were reported as follows: (mis-tlifbps group) 1 patient had a wound infection.2 patients had dural sac tear.Unknown patients had lower back pain.(llif-lsup group) 1 patient had sympathetic chain injury.2 patients had transient thigh numbness.Unknown patients had lower back pain.All patients achieved satisfactory recovery of complications with conservative management.This report is for the unknown depuy spine viper 2 system.A copy of the clinical evaluation form is being submitted with this regulatory report.This is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
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.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown viper 2 system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.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.
|
|
Search Alerts/Recalls
|
|
|