MAUDE Adverse Event Report: ZIMMER BIOMET SPINE PLATE BUTTRESS 1 HOLE TI COVER ASSY; LANX FUSION SYSTEM

Catalog Number 8606-0100

Device Problem Disassembly (1168)

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

Event Date 12/21/2016

Event Type  malfunction  

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.Reference report 3004485144-2017-00035.

Event Description

It was reported that the set screw disassembled from two cover plate assemblies while trying to install them in the patient with a high iliac crest.They were removed and replaced with other cover plate assemblies to complete the procedure.There were no reports of patient injury associated with this event.This is report one of two for this event.

Manufacturer Narrative

The returned device was examined.The set screw was found wedged against the plate as though disassembly was attempted.However, there are no indications that the device actually disassembled as reported.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

• Brand Name: PLATE BUTTRESS 1 HOLE TI COVER ASSY
• Type of Device: LANX FUSION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6256645
• MDR Text Key: 64949936
• Report Number: 3004485144-2017-00034
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606-0100
• Device Lot Number: MD52547
• Other Device ID Number: (01)00888480559665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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