MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179712640 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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This is a report of a revision case.The initial surgery on the patient was done in (b)(6) 2019.The elongation of the construct was needed due to loosening of the screws implanted in th10 vertebrae.Both of the screws were explanted and the construct was elongated to th7.The patient has parkinsons disease.Procedure/surgery name: posterior lumbar spinal construct elongation.Concomitant device reported: unknown rod (part# unknown, lot#unknown, quantity 1).This complaint involves two (2) devices.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Search Alerts/Recalls
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