WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number 394.91 |
Device Problems
Crack (1135); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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, the large ex-fix 11mm carbon fiber rod was chipping and cracking and unable to sterilize or assemble.There was no patient involvement.There is no further information available.This report is for (1) large ex-fix 11mm crbn fbr rod 600mm / mr-conditional.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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, the large ex-fix 11mm carbon fiber rod was chipping and cracking and unable to sterilize or assemble.There was no patient involvement.There is no further information available.This report is for (1) large ex-fix 11mm crbn fbr rod 600mm / mr-conditional.This is report 1 of 3 for (b)(4).
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Search Alerts/Recalls
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