MAUDE Adverse Event Report: EBI, LLC. ZYSTON ARC INTERBODY SPACER; CURVE MIS VARIABLE INSERTER

Model Number N/A

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 01/22/2015

Event Type  Injury  

Event Description

The distributor reports the tip of the mis threaded inserter broke during surgery.He reports the tip was unable to be removed from the patient.

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.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

The sales associate reported the original part number (14-533072) reported did not break and provided the correct part number.Review of device history records show that lot released with no recorded anomaly or deviation.The facility states the product will not be returned to the manufacturer for evaluation.

• Brand Name: ZYSTON ARC INTERBODY SPACER
• Type of Device: CURVE MIS VARIABLE INSERTER
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 4552526
• MDR Text Key: 5471504
• Report Number: 0002242816-2015-00013
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110650
• 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: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-533073
• Device Lot Number: PT15C
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• 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