MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CNNLTD 5.5 PLYSCRW 6.5X35; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Model Number N/A

Device Problem Disassembly (1168)

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

Event Date 10/04/2016

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.This is report one of two for this event.Reference report 3004485144-2016-00308.

Event Description

It was reported that during the procedure, the tulip of one pedicle screw became detached from the screw shank and the tulip on another pedicle screw became stuck.There is no reported patient harm or surgical delay associated with this event.

Manufacturer Narrative

Additional information: method code.The screw was not returned for evaluation.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: CNNLTD 5.5 PLYSCRW 6.5X35
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW 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: 6087648
• MDR Text Key: 59460020
• Report Number: 3004485144-2016-00302
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3505-6535
• Device Lot Number: 87WZ
• Other Device ID Number: (01)00889024335684
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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