Catalog Number 199721001S |
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 12/13/2018 |
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 mr (b)(6) was final tightening the correction key on the concavity of the curve.He tried to final tighten the set screw and this wasn¿t possible.Therefore, he tried using a unitised nut, first removing the ears and using the reduction tool.Still the nut couldn¿t be final tightened.Mr (b)(6) concluded the thread in the head of the screw had been completely stripped by the set screw and hence he decided it wouldn¿t be possible to insert and final tighten a set screw so he left it empty.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Visual examination found that the threads on the set screw 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.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 5.5 expedium verse unitized set screw cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew 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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Search Alerts/Recalls
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