MAUDE Adverse Event Report: EBI, LLC ZYSTON INTERBODY SPACER SYSTEMS; CURVE VARIABLE INSERTER SHAFT

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2014

Event Type  Injury  

Event Description

It was reported while inserting the zytson curve the surgeon was adjusting the cage and had loosened and adjusted the handle, then tightened it back up to continue inserting and the distal tip broke off in the cage.The tip was not removed from the cage and therefore remains in the patient.

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Manufacturer Narrative

A visual examination confirmed the reported event; the threaded tip of the inserter was sheared off.Due to the condition of the returned instrument a functional evaluation could not be performed.A review of the device history record (dhr) indicated that there were no dimensional, functional, or material anomalies reported at inspection.The probable underlying root cause for the damage is excessive force leading to loss of mechanical integrity and ultimately instrument fracture.

• Brand Name: ZYSTON INTERBODY SPACER SYSTEMS
• Type of Device: CURVE VARIABLE INSERTER SHAFT
• Manufacturer (Section D): EBI, LLC; 399 jefferon road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 399 jefferson road; parsipany NJ 07054
• Manufacturer Contact: michelle coldwater ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 3915905
• MDR Text Key: 4518742
• Report Number: 0002242816-2014-00053
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-533041
• Device Lot Number: PT15D
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability