Catalog Number 999803845 |
Device Problems
Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Request for english translation ongoing.
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Manufacturer Narrative
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Product complaint # : (b)(4).
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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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