Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
Abrasion (1689); Not Applicable (3189)
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Event Date 12/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Device not available for return.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional durotomy involving damage to the meninges during a bur hole as a result of this event.No further information was provided.
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Manufacturer Narrative
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Follow up with the customer in this event confirmed that no stryker product was involved in this event.The event involved a non-stryker product a adeor blade adeor, lot; unknown, manufactured by imc impomed.A letter was be sent to imc impomed notifying them of the event and also the fda.As a result the event is considered an inquiry.No stryker product was involved.: non stryker device.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional durotomy involving damage to the meninges during a bur hole as a result of this event.No further information was provided.Update; sales rep advised that no stryker device was involved in this event.No malfunction reported involving a stryker device.The device involved was a blade adeor, lot; unknown, imc impomed device.A letter will be sent to imc impomed notifying them of the event and also the fda.As a result this stryker complaint will be cancelled.As a result the event is considered an inquiry.No stryker product was involved.
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Search Alerts/Recalls
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