MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 TI UNI 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179988645 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 08/20/2019 |
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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It was reported that on an unknown date, patient was returned to the or one week post-op because surgeon suspected an infection (not related to the hardware).Since we were going to have the incision opened, the surgeon decided to retighten the screws.Almost all of them were very loose.There was no patient consequence.Procedure outcome is unknown.This complaint involves seven (7) devices.
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Search Alerts/Recalls
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