SYNTHES GMBH UNK - CAGE/SPACERS: SYNCAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
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Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); Non-union Bone Fracture (2369); Osteolysis (2377); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Insufficient Information (4580)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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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: b3 unknown event date; study ranged from 2014 to 2020 d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi 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.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.
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Event Description
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This report is being filed after the review of the following journal article: demirel, a., terzic, r., kaspersen, e., aras, e.L., eiskjaer, s.P., (2023) anterior lumbar interbody fusion (alif): complications and radiological outcomes, journal of spine research and surgery, vol.5 (3), pages 58-64 ( denmark ).The aim of this retrospective study was to report the complications and radiological outcomes of patients treated with alif using a specific peek cage (syncage evolution).Between 2014 and 2020, a total of 56 patients (male 25 and female 31) had undergone a total of 80 alif procedure with peek cage (syncage evolution) combined with a posterior instrumented fusion performed as a traditional open posterior approach.Afterwards, all patients underwent posterior fixation with different pedicle screw systems.In 30 patients a percutaneous pedicle screw system was used ¿ viper 24 (depuy synthes) and revolve 6(globus medical).In the last 26 patients expedium ¿ depuysynthes (1), legacy ¿ medtronic (1), solera ¿ medtronic (1), vitality ¿ zimmer biomet and xia ¿ stryker (16) were used.The follow up period was unknown.The following complications were reported as follows: 1 patient had a non-union at two levels.This patient continued to use non-steroidal anti-inflammatory drugs (nsaids) during the first year after surgery contradictory to the given advice.The patient got re operated with a posterior approach by insertion of tlif cages and bone graft after removal of as much as possible of the two alif cages 3 patients with venous lesions due to anterior approach (intraoperatively) which were sutured immediately and caused minimal bleeding 1 patient had rupture of the rectus abdominis and transverse fascia which needed mesh augmentation.1 patient had superficial infection of the anterior incision was treated successfully with debridement and antibiotics.4 patients had relaxations/pareses of the left rectus abdominis musculature were registered.1 patient had a posterior deep infection that was treated successfully with removal of the pedicle screws and rods on one side and debridement and antibiotics for 6 weeks.2 patients with adjacent level degenerations were registered and treated with fusion decompression.In an unknown number of patients, the mean subsidence was 1-2mm in the first year after surgery depending on the level.This report is for an unknown synthes syncage for (b)(4).A copy of the literature article is being submitted with this medwatch.
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