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Catalog Number 07.702.016S |
Device Problem
Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2023 |
Event Type
malfunction
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Event Description
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Device report from depuy synthes reports an event in japan as follows: it was reported that during osteoporotic vertebral fracture (ovf) surgery performed on (b)(6) 2023, the cement that had been refrigerated normally was taken out of the refrigerator and when used, the cement hardened too fast and got unusable.The surgery was completed successfully with no surgical delay.There was no patient consequence.No further information is available.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: device history record (dhr) review conducted: part # 07.702.016s.Lot # 2g53520.Manufacturing site: werk selzach logistik release to warehouse date: 01.July.2022 supplier: (b)(4).Expiration date: 01.July.2025.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D10: added concomitant devices and therapy date.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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