Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product is not decontaminated, no product evaluation is available.The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Current information is insufficient to permit a valid conclusion about the cause of this event.More information are requested.
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Event Description
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Roi-a : broken cage during impaction.Description of complainant: steril cage broke during patient insertion, broken implant-holder, which according to surgeon has break the cage.The broken cage, and the broken instrument parts were removed.And x-ray was done to check that everything has been removed.
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Manufacturer Narrative
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Fields were updated for this report.Severals attempts were made to collect more informations on this event.First product examination shows that the returned component may come from the head of a roi-a implant holder.However the inspection of the alleged returned instrument show that it contain all it pieces.Clarifications were asked to the reporter.No updates still received.Investigation still in progress.
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Event Description
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Roi-a : broken cage during impaction.Update on july 19th 2018.Several attempts were made to obtain more information about the event and no further information on this complaint has been provided.An initial examination of the returned parts shows that they can come from the head of a roi-a cage holder.However the returned, instrument has no missing parts.Clarifications were requested from the reporter.Investigation still in progress.
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Manufacturer Narrative
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This medwatch is submitted to send the result of the investigation of this complaint.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Based on the product history records, the review of the case and the recurrence of this type of event for this implant, the root cause of the event cannot be determined.Requests for additional information did not receive a response.It's possible that the surgeon performed a poor positioning, which combined with a possible condition of hard bones of the patient, caused the breaking of the cage.However, for the lack of information received from the reporter this hypothesis could not be validated.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: undetermined.If additional informations were received that allow to drawn a conclusion for this case , another report will be sent.
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Search Alerts/Recalls
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