MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ENDPLATE, LARGE, 3 DEGREES; INFIX ANTERIOR LUMBAR SYSTEM

Catalog Number 1801-503

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference reports 3012447612-2017-00640 - 3012447612-2017-00642.

Event Description

It was reported that a strut did not successfully assemble with the two mating end plates within surgery.All three devices were removed and replaced with alternative devices.There were no reports of patient impacts associated with this event.This is report two of three for this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned endplate was evaluated.There were gouges and scuff marks on the device indicative of attempted use.During a functional check, the endplate was assembled and locked with the mating strut and endplate; there was not a device failure found.The cause is likely attributed to improper alignment of the devices or improper seating on the inserter during attempted assembly and locking.A review of the manufacturing records did not identify any issues which may have contributed to this event.

• Brand Name: ENDPLATE, LARGE, 3 DEGREES
• Type of Device: INFIX ANTERIOR LUMBAR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7027709
• MDR Text Key: 92917789
• Report Number: 3012447612-2017-00641
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1801-503
• Device Lot Number: P204K
• Other Device ID Number: (01)00889024331129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 78