Catalog Number 04.614.508S |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: device was used for treatment, not diagnosis.Patient information not available for reporting.Original implant date is unknown, device is still implanted.Device is not expected to return; it is currently still implanted.Contact phone number is not available.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the set screw had been dislodged postoperatively on an unknown date.X-rays taken on an unknown date determined that the screw had migrated.Revision surgery will be required but is not currently scheduled.It is unknown when the original surgery took place.(b)(4).
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Manufacturer Narrative
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Product code, common device name.Additional product codes: kwp, mnh, mni.Device was used for treatment, not diagnosis.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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.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 has been reported that re-operation is not planned for the time being.
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Search Alerts/Recalls
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