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Catalog Number 07.702.016S |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: only the event year is known.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown biomaterial - cement: spine /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name:(b)(6).E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that this was a thoracolumbar posterior fusion for a th12 burst fracture on (b)(6) 2023.In the surgery, a posterior fusion (th11-l1), cement augmentation (th11/l1), and a vertebroplasty (th12) using biopex were done.Using an image intensifier from the lateral, the surgeon inserted the screw to the right of th11 while confirming that there were no problems with the trajectory or angle.After screws were inserted in all other planned positions, the cement was injected.The surgeon injected the cement while checking the state using an image intensifier from the lateral, and there were no particular abnormalities.The surgery was completed successfully with no surgical delay.After surgery, ct scans showed that the cement had flowed into the pedicle.The amount of cement that flowed out is unknown.The surgeon commented that there was no impact on the patient, and that the cause of the cement leakage was that when the screw was replaced during surgery to change the trajectory, it grazed the spinal canal, causing a crack.No further information is available.This report involves one unk - biomaterial - cement: spine.This is report 1 of 1 for (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.G4: device is not distributed in the united states, but is similar to device marketed in the usa.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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