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 Consequences Or Impact To Patient (2199)
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Event Date 05/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (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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"procedure: revision of thoraco lumbar fixation the heads of the screws are fixed in one position and can't be unlocked for removal, which create issue to remove them.The surgeon had to put a lot of force to unlock 2 head.This can have a dangerous consequence on the patient.The locked screw was difficult to remove, the hammer needed to be used to enter the x25 screwdriver into the screw shaft".
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Manufacturer Narrative
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Product complaint # (b)(4).Visual examination of the verse correction key signs of operative use as evidenced by superficial markings, with significant damage to the threads of an outer screw.It was noted that the set screws had its outer threads peeled while the inner screw drive feature is slightly damaged.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 threads on the verse correction key cannot be determined.However, a potential root cause may have occurred due to cross-threading a set screw upon insertion.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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