MAUDE Adverse Event Report: ZIMMER SPINE, INC. ARDIS INSERTER - 9MM

Model Number 3256-02

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Same case as: 21084052-2014-00117.It was reported that implant disengaged from the inserter during surgery.Levels treated were l5-s1.An ardis implant was to be placed at l5-s1 as well.As the surgeon was attempting to correct the trajectory of the cage, while malleting, the inserter unscrewed from the implant and popped off the inserter.The surgeon was not able to re-attach the inserter to the implant.An extraction tool was used to remove the implant.The surgeon then used the same size implant and the same inserter to complete the case.There was no harm to the patient and about a five minute delay to the case.

• Brand Name: ARDIS INSERTER - 9MM
• Type of Device: ARDIS INSERTER - 9MM
• 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: 4212926
• MDR Text Key: 5153724
• Report Number: 2184052-2014-00116
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131242
• 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: 07/09/2014

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: 3256-02
• Device Catalogue Number: 3256-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 113