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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00864-1
Product Name/Description Medtronic Spinous Process Clamps

Spine Referencing Instrumentation

Model/Catalogue Numbers

9734715 Spinous Process Clamp, Tall
9734716 Spinous Process Clamp, Short
9734723 Double Spinous Process Clamp, Tall
9734724 Double Spinous Process Clamp, Short

9734715K Spinous Process Clamp, Tall
9734716K Spinous Process Clamp, Short
9734723K Double Spinous Process Clamp, Tall
9734724K Double Spinous Process Clamp, Short

9735500 Set (contains 9734715 & 9734716)

ARTG Number: 125074
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 18/07/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue 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.
Medtronic has received six reports where unintended removal of spinous process occurred when attempting to detach the Spine Clamp. The unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is providing an interim workaround for users via the Customer Letter. A new version of the clamps with a design mitigation will be distributed as a permanent correction once available.

This action has been closed out on the 11/10/2018.
Contact Information 02 9857 9000 - Medtronic