Medtronic Spinous Process Clamp

Starting date:

July 17, 2017

Posting date:

September 5, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-64412

• Reason
• Affected products

Reason

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.

Affected products