MAUDE Adverse Event Report: ZIMMER BIOMET SPINE PLATE 2 HOLE TI 8MM ASSY; LANX FUSION SYSTEM- SA

Model Number N/A

Device Problem Disassembly (1168)

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

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

The returned devices were visually examined and the complaint was confirmed.The dhr was reviewed; there were no manufacturing issues detected which would have contributed to this event.

Event Description

As the surgeon was final installing the screws through the plate, the plate's set screw dissociated from the plate.The plate and set screw were successfully removed from the patient and were replaced by another copy of the same size.This replacement also dissociated and was successfully removed and replaced with a plate of a different size.There was no reported injury to the patient.

• Brand Name: PLATE 2 HOLE TI 8MM 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 pkwy ste. 120; suite 120; broomfield CO 80021
• Manufacturer Contact: teresa george ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5988772
• MDR Text Key: 55987693
• Report Number: 3004485144-2016-00222
• Device Sequence Number: 1
• Product Code: MAX
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8605-0208
• Device Lot Number: WO130420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention