STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE
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Catalog Number 657316S |
Device Problem
Material Fragmentation (1261)
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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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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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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Search Alerts/Recalls
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