Model Number 101-9812 |
Device Problem
Migration (4003)
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Patient Problems
Therapeutic Effects, Unexpected (2099); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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No code available was used as there is no equivalent fda code for surgery.
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Event Description
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It was reported that a patient's spacer implant was removed due to ineffective therapy.During the explant procedure, the physician noticed that the spacer had dislodged from it's original location.The patient has fully recovered following the explant procedure.
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Event Description
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It was reported that a patient's spacer implant was removed due to ineffective therapy.During the explant procedure, the physician noticed that the spacer had dislodged from it's original location.The patient has fully recovered following the explant procedure.
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Manufacturer Narrative
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The returned spacer implant was analyzed, passed all tests performed, and exhibited normal device characteristics.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, failure of the device/procedure to improve symptoms and/or function is noted within the dfu as a potential complication associated with the use of the device.The reported event was not confirmed.The spacer implant device history record review revealed no additional information related to the complaint.The patient's spacer implant was explanted due to ineffective treatment.The investigation has assigned a probable cause of known inherent risk of device.
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Search Alerts/Recalls
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