Mectalif Oblique

Description of Event or Problem

On (b)(6) 2026, an Oblique Spacer was implanted at the L3D L4 level in a 75-year female patient weighing approximately 75D 80 kg and with a slightly elevated BMI. The indication for surgery was grade 1 degenerative spondylolisthesis. According to the surgeon, the primary procedure was uneventful, and neither the spacer nor the implantation instruments showed any damage or functional issue. Following the procedure, CT and MRI examinations revealed subsidence of the cage into the endplate and dorsal migration toward the foramen, resulting in significant nerve-element compression, so patient pain. A remodeling zone was observed around both the cages and the screws, consistent with implant loosening. The competitor`s screwD rod connections remained intact; however, after removal of the locking screws and rods, the screws were found to be severely loose and could be removed with minimal force. No signs of metallosis were observed around the screws. Conversely, the surgeon reported significant black discoloration, described as metallosis, throughout the cavity surrounding the spacer and the autologous bone graft placed inside it. No photographs of this finding (metallosis) were available. Revision surgery was performed on (b)(6) 2026. The surgeon replaced the loosened screws with screws two sizes larger and implanted a cage one or two sizes larger. The new cage was impacted beyond the remodeling area, rotated further than usual to obtain support on the wedge-shaped bone surface, and filled with autologous and allogeneic bone graft. The patient was reported to be doing well following the revision.

Additional Manufacturer Narrative

Batch review performed on 17 July 2026: Lot 2563463: (b)(4) items manufactured and released on 20-Oct-2025. Expiration date: 30-Sep-2030. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Clinical evaluation performed by Medacta Medical Affairs Manager: Early failure of the L3-L4 construct occurred, characterized by cage subsidence and posterior cage migration. Marked loosening of the posterior pedicle screws, manufactured by a competitor, was also reported. The available CT images confirm both cage subsidence and posterior migration. These findings are compatible with insufficient primary stability and/or loss of mechanical stability during the early postoperative period, before achievement of solid fusion. The precise root cause cannot be determined from the available information. Potential contributing factors include patient-specific bone quality, previous spinal surgery, cage-endplate support, implant positioning, posterior fixation stability, and other surgical or biomechanical factors. The resulting instability may have led to repetitive cage micromotion. In the context of subsidence and posterior migration, such micromotion could plausibly have contributed to the observed loss of the titanium coating. This finding may also be compatible with the black peri-cage material reported intraoperatively and described as metallosis; however, this diagnosis has not been confirmed by histological or elemental analysis. Although the chronological sequence cannot be established with certainty, the available evidence suggests that the coating loss was more likely a secondary consequence of cage micromotion, subsidence, and migration than the primary initiating event. Nevertheless, an intrinsic coating-related issue cannot be excluded without technical analysis of the explanted device. The root cause cannot be definitively determined based on the available information; however, the event is considered likely multifactorial. Visual Inspection performed by Medacta Spine R&D Project manager: A MectaLIF Oblique cage, was reportedly implanted at L3-L4 and subsequently removed due to device subsidence and posterior migration. Based on the picture received, damage to the endplate-contacting surface of the cage was observed, with apparent removal of the coating. According to the information received, the cage was used in combination with a competitor`s pedicle screw system. During the revision surgery, the pedicle screws were reportedly found to be loose, and there were signs of metallosis. Based on the currently available information, screws loosening may have contributed to insufficient primary stability of the construct. This condition may have resulted in repetitive micromotion of the cage, potentially contributing to damage of the cage surface, coating removal, and the reported presence of titanium residues. Visual inspection of the MectaLIF Oblique cage showed wear localized on only one side of the cage. This wear pattern is consistent with the hypothesis of repetitive micromotion associated with construct instability. Based on the available information, including the reported loosening of one pedicle screw during revision surgery and the localized wear observed on the returned cage, construct instability remains a plausible contributing factor to the cage damage, coating removal, and reported metallosis No clear evidence of a technical issue or manufacturing defect of the MectaLIF Oblique cage was identified during the visual inspection. The reported screw loosening and resulting construct instability are considered possible contributing factors to the reported cage damage, subsidence and posterior migration. Root cause:Based on the information available, the event is considered likely multifactorial, and no definitive root cause can be established. Early loss of construct stability, including marked loosening of the competitor¿s pedicle screws, may have resulted in repetitive cage micromotion, contributing to cage subsidence, posterior migration, coating damage, and the reported peri-cage black material. The coating loss is considered more likely a secondary consequence of construct instability than the initiating event. There is no indication that any potential issue with the device may have caused or contributed to the event, and the the investigation does not indicate any potential manufacturing-related issue.