MAUDE Adverse Event Report: ZIMMER BIOMET SPINE PLATE 4 HOLE TI 6MM ASSY; LANX FUSION SYSTEM- SA

Catalog Number 8605-0406

Device Problem Disassembly (1168)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 report 3004485144-2016-00423.

Event Description

It was reported that the during final tightening onto the spacer in surgery, the set screw detached from the plate assembly.The spacer was implanted without the plates since the threaded hole was damaged on the spacer.There are no reports of patient injury associated with this event.This is report two of two 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 device was examined.The set screw has detached from the plate.Additionally the threads and the drive hex on the set screw are damaged.Based on the damaged noted, an incompatible device may have been used to assemble this device to the mating spacer.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain instructions regarding device proper usage, including insertion and assembly.

• Brand Name: PLATE 4 HOLE TI 6MM ASSY
• Type of Device: LANX FUSION SYSTEM- SA
• 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: 6220500
• MDR Text Key: 63801700
• Report Number: 3004485144-2016-00424
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123767
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605-0406
• Device Lot Number: MD54639
• Other Device ID Number: (01)00888480559603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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