PREMIA SPINE LTD. PROMIS FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 86132 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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Review of the manufacturing records of the involved implant was performed and it was found that the lot was manufactured in accordance with specifications and no discrepancies were found.The explants were not obtained for investigation.However, there was no indication of hardware failure, the surgeon replaced only two screws with new premia spine screws of larger diameter and indicated that the loosening was due to spondylodiscitis.Screw loosening is a known complication in spinal fusion and in orthopedic surgeries in general and may be attributed to multiple factors including bone quality, patient's age and weight bearing forces.The rate of screw loosening in premia spine procedures is much lower than the rates reported in the literature for spine fusion procedures.Altogether, it is assumed that the loosening is related to the disease/technique rather than to a device failure.
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Event Description
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Patient implanted with the promis fixation system in germany, underwent revision surgery after 6 weeks due to screw loosening.The original procedure was performed on (b)(6), 2023 due to stenosis and spondylodiscitis and included fusion at l5-s1.In the revision surgery, two pedicle screws in s1 vertebra were replaced by two new larger diameter pedicle screws.L5 screws remained in-situ and rods were re-used.According to the surgeon who performed the revision procedure, the reason for screw loosening was spondylodiscitis.
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