MAUDE Adverse Event Report: ZIMMER SPINE ENDPLATE, LARGE, 3

Model Number 1801-503

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/06/2014

Event Type  malfunction  

Event Description

Same case as: 2184052-2014-00059, 00057, 00056, 00054, 00055.It was reported that during surgery the surgeon had trouble implanting the infix implant.The first set of 8mm struts started to scissor, so they were put aside and the surgeon loaded two new 8mm struts in the guides.After trying to lock the construct the locker did not work.The surgeon looked and saw the 8mm struts had scissored and damaged the endplate.The surgeon used different sizes struts was able to successfully complete the surgery.

Manufacturer Narrative

Visual analysis of the returned device confirmed the reported event.Manufacturing records reviewed indicated no deviations or anomalies.It is not suspected that the product failed to meet specifications.The most probable root cause of this event was operational context as the device performance was limited by procedural/anatomical factors.The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may or may not be factually correct.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

• Brand Name: ENDPLATE, LARGE, 3
• Type of Device: ENDPLATE, LARGE, 3
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 3808184
• MDR Text Key: 20857485
• Report Number: 2184052-2014-00058
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1801-503
• Device Catalogue Number: 1801-503
• Device Lot Number: 78JZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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