Catalog Number 91-9509SC / 519250 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Event Description
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According to available information, this device required replacement due to a wire break.No other adverse patient effects were reported.
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Manufacturer Narrative
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Examination of the device revealed that both rods were unable to maintain the retention angle.The rods were bent in four directions into approximately 45-degree angle but did not hold angle.With use over time, the coil inside the device may fatigue which could result in the loss of angle retention.Based on the testing, it was confirmed that the inner core of both rods most likely fractured.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Event Description
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According to the available information this genesis malleable was revised due malfunction (wire breakage).
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Search Alerts/Recalls
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