MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLATE BUTTRESS 1 HOLE TI 10MM ASSY; LANX FUSION SYSTEM

Catalog Number 8605-0110

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2016

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.

Event Description

It was reported that the set screw detached from a plate assembly during a demonstration.There was no related surgery or patient involvement with this event.

Manufacturer Narrative

Additional information: the returned plate assembly was evaluated.The c-ring remains attached to the set screw and both have dissociated from the plate.The c-ring was slightly bent, likely from the dissociation process.The cause is possibly attributed to off-axis forces placed on the set screw during attempted assembly with the mating spacer.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: PLATE BUTTRESS 1 HOLE TI 10MM ASSY
• Type of Device: LANX FUSION 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: 6675796
• MDR Text Key: 78691016
• Report Number: 3012447612-2017-00264
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605-0110
• Device Lot Number: MD51877
• Other Device ID Number: (01)00888480559467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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