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

Model Number 1801-503

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Same case as mfr id: 2184052-2014-00083, 00081.The pt was undergoing an anterior lumbar interbody fusion surgical procedure from l5-s1 using infix instrumentation.A construct was assembled in the disc space but was not yet locked.A lateral x-ray was taken to confirm position.Lucency was observed between the superior endplate and struts.The implant was removed and attempted again with the same implant with the same outcome.The implant was then removed and replaced with another and was successfully assembled and implanted.This event resulted in a 10 minute delay.There was no pt impact.

Manufacturer Narrative

Age - late 40s.Eval of the returned device was consistent with 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 is operational context.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: INFIX
• 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: 3868797
• MDR Text Key: 16223976
• Report Number: 2184052-2014-00082
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• 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: 74SN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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
• Patient Weight: 82