Catalog Number 36-2018 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2023 |
Event Type
malfunction
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Event Description
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The customer alleged that during a decompression posterior lumbar with fusion extension to l1 and anterior lumbar interbody fusion with vascular assist, one side of the jaws broke off entirely.The piece fell into the patient and was retrieved with no further harm to the patient.
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Manufacturer Narrative
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The complaint was confirmed via pictures provided by the customer.However, the picture provided did not show any of the markings on the device to determine the lot number of the device.The device was discarded after the pictures were taken.Therefore, the device cannot be returned and no more pictures can be taken.Without further information, a true root cannot be determined.The complaint has been logged in the complaint system for tracking and trending.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a subsequent follow up report will be submitted.There has been a total of (b)(4) sold of all lots with no additional complaints recorded for the jaw breaking off.Therefore, this is an isolated event.Received via user facility report# (b)(4).
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Manufacturer Narrative
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The customer notified symmetry on 10/09/2023 that the device was found and available for returned.Upon receiving the device, it was evaluated and confirmed to have a manufactured date of 1410 ( oct 2014).The device showed significant signs of wear and tear and a dard spot on the break that indicitive that the jaw was cracked for sometime before the jaw broke off during the procedure.The crack could have occurred during another case, or it could have been mishandled during cleaning.Based on the product review and the risk assessment no further actions are necessary.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.
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Search Alerts/Recalls
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