MAUDE Adverse Event Report: AMENDIA SYZYGY STABILIZATION SYSTEM; PEDICLE SCREW FIXATION SYSTEM

Model Number 85-03M

Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

Device implanted.

Event Description

Medial coupler component of the construct malfunctioned in that it did not allow the screw/rod construct to be reduced, thereby compromising the device's therapeutic effectiveness since the spondylolisthesis at that level could not be treated.The chance is more than remote that the patient will require further intervention, which would constitute an injury per fda guidance.

Manufacturer Narrative

An evaluation of the device could not be performed as it was not returned.The reported complication could not be duplicated with representative devices and is likely related to surgeon technique.A technique recommendation that may prevent a recurrence of the reported event will be communicated to the surgeon.

• Brand Name: SYZYGY STABILIZATION SYSTEM
• Type of Device: PEDICLE SCREW FIXATION SYSTEM
• Manufacturer (Section D): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer (Section G): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: bruce hooper ; 1755 west oak parkway; marietta, GA 30062 ; 8777553329
• MDR Report Key: 6532254
• MDR Text Key: 74178328
• Report Number: 1067095-2017-00007
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 85-03M
• Device Lot Number: 77-16089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1