Model Number 25-879-07-91 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Impaired Healing (2378)
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Event Date 11/23/2021 |
Event Type
Injury
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Event Description
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It was reported that two screws became loose due to patient's anatomy.They were removed and replaced.
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Manufacturer Narrative
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An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.Based on the information provided the results conclude that the most likely root cause is patient related.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Event Description
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It was reported that two screws became loose due to patient's anatomy.They were removed and replaced.
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Manufacturer Narrative
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An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.Based on the information provided the results conclude that the most likely root cause is patient related.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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