Model Number 482807045 |
Device Problem
Migration (4003)
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Patient Problem
Injury (2348)
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Event Date 01/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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Visual inspection: visual inspection indicates that rod dent on 2 of the returned blockers is not uniform on both sides of the blocker implying that the rod might not be placed horizontally in the screw head.Review of x-rays also indicates that one of the rods was placed at an angle and may not be fully contacting the blockers.No visual anomaly was noted on 2 blockers.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From es2 surgical techniqe: use the counter torque tube as an insertion tube to facilitate the alignment of the blocker within the blades to prevent cross-threading.The counter torque tube can also be used to help direct the rod downward into the screw head if the rod is slightly proud.Final tightening of the blockers is performed using the counter torque tube and the torque wrench.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Caution: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head, the rod is high in the screw head, and/or an acute convex or concave bend is contoured into the rod.Based on surgical technique and inspection of returned products and x-rays, most likely cause of reported event is rod not fully contacting the blockers in the initial construct / off-loading on blockers.
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Event Description
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It was reported that 4 mantis redux blockers and 2 rods, implanted in l2/l3, migrated post-operatively.Revision surgery has occurred.This report represents the second of the two rods.
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Manufacturer Narrative
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Visual inspection: visual inspection indicates that rod dent on 2 of the returned blockers is not uniform on both sides of the blocker implying that the rod might not be placed horizontally in the screw head.Review of x-rays also indicates that one of the rods was placed at an angle and may not be fully contacting the blockers.No visual anomaly was noted on 2 blockers.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified as all units met stryker specifications.From es2 surgical technique: use the counter torque tube as an insertion tube to facilitate the alignment of the blocker within the blades to prevent cross-threading.The counter torque tube can also be used to help direct the rod downward into the screw head if the rod is slightly proud.Final tightening of the blockers is performed using the counter torque tube and the torque wrench.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Extra caution is advised in the following cases: the rod is not horizontally placed into the screw head, the rod is high in the screw head, and/or an acute convex or concave bend is contoured into the rod.Based on surgical technique and inspection of returned products and x-rays, most likely cause of reported event is rod not fully contacting the blockers in the initial construct / off-loading on blockers.
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Event Description
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It was reported that 4 mantis redux blockers and 2 rods, implanted in l2/l3, migrated post-operatively.Revision surgery has occurred.This report represents the second of the two rods.
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Search Alerts/Recalls
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