Product Wiki · Recalls · Health Canada — Medical Devices

Medtronic Spinous Process Clamp — recall 57412

Health Canada — Medical Devices · Canada · 2017-09-05 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57412
Date of alert
2017-09-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient's spinous process. When the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. The washer could then be inadvertently left behind in a patient's body if the breakage occurs during the procedure. If the washer is missing from the device, the spine clamp cannot be re-opened after placement on the spinous process. The unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation. This notification is intended to provide instructions to help healthcare practitioners identify whether a spine clamp has been damaged prior to use.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/medtronic-spinous-process-clam

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