MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 199721745 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during the a surgery on (b)(6) 2019, dr.(b)(6) became aware that the inner thread of screw was defective.The surgeon had to remove the screw and rod, because the locking screw could not screw in.A new screw has been inserted and a surgery delay of 30 min occured.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Udi: (b)(4).Visual examination of the screw revealed that the threads of the tulip head were torn off completely.Some pieces of the torn thread of the tulip head were stuck in between the threads of correction key.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn thread of the tulip head cannot be determined.Noted damage suggests that inadvertently cross threading of the correction key occurred upon insertion into the tulip head.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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