MAUDE Adverse Event Report: ZIMMER SPINE, INC. ENDPLATE, SMALL 3

Model Number 1801-103

Device Problems Bent (1059); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Same case as: 2184052-2014-00129, 2184052-2014-00128, 2184052-2014-00130.It was reported the implant would not lock properly during surgery.When advancing the struts into the endplate, the struts "scissored" at the anterior end of the endplate.The surgeon was unable to lock the implant.The parts were removed from the pt and the case was completed with a competitor product.

Manufacturer Narrative

Add'l relevant info will be provided when the device eval is completed.

• Brand Name: ENDPLATE, SMALL 3
• Type of Device: ENDPLATE, SMALL 3
• Manufacturer (Section D): ZIMMER SPINE, INC.; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4219061
• MDR Text Key: 20267028
• Report Number: 2184052-2014-00127
• Device Sequence Number: 1
• Product Code: KWP
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1801-103
• Device Catalogue Number: 1801-103
• Device Lot Number: 78YM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1