Model Number 25-092-08-91 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report:
mdr 9610905-2018-00153.
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Event Description
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It was reported the screw stripped then broke off at the head.
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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 falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.Due to no device being returned the failure root cause cannot be determined.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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Manufacturer Narrative
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Fda notified us of our follow up for this event is skipping in sequence.Identified a typo g7.Corrected follow- up#: 2 to follow-up#: 1.No additional information was received.
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Search Alerts/Recalls
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