Catalog Number 657312S |
Device Problems
Material Fragmentation (1261); Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: ''orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head." no further information has been provided.
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Event Description
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As reported: ''orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head." no further information has been provided.
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Manufacturer Narrative
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Correction - please refer to h6 device code.This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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Search Alerts/Recalls
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