Catalog Number IG007R |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Numbness (2415)
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Event Date 03/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
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Manufacturer Narrative
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Corrections in d4: lot number and udi number, d9, and h3.Additional information in h4.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
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Event Description
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It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no apparent issues with the device.Functional testing revealed that the ratcheting mechanism is working correctly and maintaining full engagement with every tooth even under tension.Root cause: root cause was unable to be determined as no product issue could be identified.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Search Alerts/Recalls
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