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 revealed signs of operative use as evidence by superficial markings, with threads and drive feature worn/damaged but not torn.It was noted that the base of the correction key appears warped.Mechanical forces on the correction key would have resulted in the base becoming warped.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 a definitive root cause for the threads of the correction key becoming worn/warped cannot be positively determined.However, the noted damage suggests that the correction keys were likely subjected to unanticipated mechanical forces during the tightening process, resulting in the base becoming warped.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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