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Model Number BG UNK |
Device Problems
Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Spinal Column Injury (2081); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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Event Description
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According to the initial report the (b)(6) distributor reported that a neurosurgeon was not happy with bioglue after a procedure.Additional information received relayed that 5 ml of bioglue was used in a spine stabilization procedure.The bioglue was applied to an infected field, and used as an adjunct to sutures.No other materials were used for reinforcement with bioglue applied over.The bioglue did not polymerize, and it was allowed the full 2 minutes for polymerization to occur.This surgeon is a frequent user of bioglue.The bioglue was removed from the patient, but it was not sent to pathology for any testing.All preparation steps were followed from the ifu.The syringe was primed and de-aired.A standard tip was used for the application of the bioglue.No other preparation steps were performed outside of those within the ifu.Subsequent information received relayed that the tissue was already infected when bioglue was applied.A re-operation was performed and it was found the bioglue had not polymerized.The surgeon was working on the vertebrae.The patient is doing well.No additional information will be forthcoming.
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Event Description
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According to the initial report the slovakia distributor reported that a neurosurgeon was not happy with bioglue after a procedure.Additional information received relayed that 5 ml of bioglue was used in a spine stabilization procedure.The bioglue was applied to an infected field, and used as an adjunct to sutures.No other materials were used for reinforcement with bioglue applied over.The bioglue did not polymerize, and it was allowed the full 2 minutes for polymerization to occur.This surgeon is a frequent user of bioglue.The bioglue was removed from the patient, but it was not sent to pathology for any testing.All preparation steps were followed from the ifu.The syringe was primed and de-aired.A standard tip was used for the application of the bioglue.No other preparation steps were performed outside of those within the ifu.Subsequent information received relayed that the tissue was already infected when bioglue was applied.A re-operation was performed and it was found the bioglue had not polymerized.The surgeon was working on the vertebrae.The patient is doing well.No additional information will be forthcoming.
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Manufacturer Narrative
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Based on the information available at the time of this report, there is not enough evidence to definitively determine the cause of the observed event.Per the product¿s instruction¿s for use (ifu), the following warning is stated: ¿do not use bioglue in the presence of infection and use with caution in contaminated areas of the body¿.There is insufficient information available to definitively determine the root cause of the reported events.It is stated in the report that bioglue was applied to an infected field.There are adequate precautions and warnings in the ifu stating to not use bioglue in the presence of infection.No further action required.The reported event could not be confirmed.No sample received and the lot number is unknown.No new risks were identified during the course of the risk management departmental complaint investigation.There are adequate precautions and warnings in the ifu stating not to use bioglue in the presence of an infection.All risks identified have been mitigated as far as possible and residual risk is acceptable.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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Search Alerts/Recalls
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