MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 4986045

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.

Event Description

Pre-op diagnosis: spinal canal stenosis procedure: oblique lumbar interbody fusion levels operated: l2/3, l3/4 it was reported that during surgery, the grasping mechanism of the cage broke.It was confirmed that inserter could no longer grasp the cage when detaching the cage from it.No narrowing of the intervertebral disc was observed, and the cage was seemed to be inserted parallel against the intervertebral disc.Patient complications were reported as unknown.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7147186
• MDR Text Key: 95917385
• Report Number: 1030489-2017-02567
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169190733
• UDI-Public: 00643169190733
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4986045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1