MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLATE 2 HOLE TI 12MM ASSY; LANX FUSION SYSTEM- SA

Catalog Number 8605-0212

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

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 became detached from the plate while being assembled to the spacer during surgery.The plate and set screw were removed and replaced with an alternative plate assembly.There was no impact to the patient.

Manufacturer Narrative

The returned plate assembly was evaluated.The set screw was dissociated from the plate.The c-ring around the set screw was found bent so that it no longer fits within its slot.This lot was manufactured prior to an incremental design enhancement which was implemented to reduce the occurrence of the set screw dissociating from the plate.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: PLATE 2 HOLE TI 12MM ASSY
• Type of Device: LANX FUSION SYSTEM- SA
• 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: 6602961
• MDR Text Key: 76394737
• Report Number: 3012447612-2017-00130
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605-0212
• Device Lot Number: MD38254
• Other Device ID Number: (01)00888480559528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• 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