Model Number 16-2840/02 |
Device Problems
Defective Component (2292); Connection Problem (2900); Detachment of Device or Device Component (2907)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 10/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in progress.
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Event Description
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It was reported that a defective connection component was replaced with a new connection component during a revision surgery.
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Manufacturer Narrative
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The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.
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Event Description
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It was reported that revision surgery was conducted to explant a dislocated connection component.
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Search Alerts/Recalls
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