Model Number 47127 |
Device Problems
Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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No evaluation possible at this time.The implants have not been removed from the patient nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
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Event Description
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Post op x-rays taken (b)(6) 2019 revealed two set screws had loosened and dislodged from both polyaxial screws.The arsenal construct was implanted on (b)(6) 2019 during a revision surgery for the same type of occurrence (ref.Mdr 2027467-2019-00022).
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Manufacturer Narrative
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The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
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Manufacturer Narrative
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The set screw bottom surface is the surface that interacts with the rod to create a stable construct, therefore the wear pattern on these surface were inspected.The expected contact surface between set screw and rod after fully tightened results in two inline marks on the set screw (2 of 4 explant set screws).1 of 4 explant set screws displayed a "starburst" wear pattern on the bottom surface of the set screw which is indicative of motion between rod and screw.1 of 4 explant set screws displayed a random wear pattern, with some "starburst" wear pattern except isolated to a single side.The tulip and set screw had no significant wear or shear/deformation of the threads.The tulip internal geometry did not display any significant wear.Investigation of the rods shows translation/slip of the mating set screw at one of the extreme ends (on both rods).Therefore, the set screw disengagement may be attributed to repeated motion at the rod-screw interface resulting in set screw back out and resulting in translation/slip along the rod.
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Search Alerts/Recalls
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