MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 199721000 |
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 03/08/2019 |
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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The following event was reported: both screwdriver part codes fail at the moment of blocking the expedium verse system, when reviewing the distal tip it is evidence that it deteriorated despite being a new instrument.At the moment of placing the double-pass bushes (code: 199721000) with the screwdrivers, they are stolen.It tries to close, and the screwdrivers do not work with the torque handle 299704320.The surgeon wants to close and notices that the cap is damaged place another bushing and when you want to do the final torque the x25 inserter screwdriver piece does not block.The surgery was extended for approximately 5 hours.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Visual examination of the correction key found that the drive feature of the rod lock were worn.It was noted that the initial threads on the poly lock were torn.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 with the information provided, a definitive root cause for the torn threads on the verse correction key cannot be determined.Noted damage suggests that inadvertently cross threading of the poly lock 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, 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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