Catalog Number 03.52.323 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 07 november 2019.Lot 1921243: 200 items manufactured and released on 05-jul-2019.Expiration date: 2024-06-19.No anomalies found related to the problem.To date, 83 items of the same lot have been already sold without any other similar reported event.Other device involved in the event: pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm lot.1922914 (k141988).Batch review performed on 07 november 2019.Lot 1922914: 200 items manufactured and released on 23-sep-2019.Expiration date: 2024-08-27.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any other similar reported event.
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Event Description
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The enh.Poly-axial pedicle screw - cannulated 6x40mm was inserted, but the screw loosening was confirmed after inserting the screw completely into the bone.One possible reason was the pedicle screw thread was not fully designed near the pedicle screw tulip, so the thread could not be fixed at the cortical bone completely and it was not able to obtain the fixing force.Pedicle screw was replaced with the backup pedicle screw.Due to this event the surgery was prolonged about 20 minutes.Patient bone quality was not good.
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Manufacturer Narrative
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Visual inspection performed by r&d project manager: the pedicle screw, ref 03.52.323, lot 1921243, is according to the specification.The potential root cause of the event is the poor quality of the bone of the patient.
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Search Alerts/Recalls
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