MAUDE Adverse Event Report: SPINEFRONTIER INC. PEDFUSE

Model Number 01-80101

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records establishes that this lot of set screw was manufactured, inspected and released to distribution with out any nonconformances.Spinefrontier investigation into this matter establishes the root cause of the occurrence was directly related to aligning the set screw.The surgical technique includes adequate instructions on set screw alignment and actions to take if the set screws does not advance with minimal resistance.The surgeon placing the device has several years of experience implanting this device and has completed numerous successful surgeries without complications.Factors relating to patient anatomy may have contributed to the reported occurrence.Spinefrotier is considering this incident closed without the need for any additional actions.

Event Description

Spinefrontier sales representative reported that the surgeon encountered difficulty advancing the set screw into the tulip during initial placement.The set screw got cross threaded during the process and had to be replaced.This was the second set screw cross threading occurrence during this case.The first occurrence was reported under mdr 3005977257-2019-00004.

• Brand Name: PEDFUSE
• Type of Device: PEDFUSE
• Manufacturer (Section D): SPINEFRONTIER INC.; 350 main st; second floor; malden MA 02148
• Manufacturer (Section G): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• Manufacturer Contact: josh harkess ; 350 main st; second floor; malden, MA 02148 ; 9782323990
• MDR Report Key: 8622112
• MDR Text Key: 145665416
• Report Number: 3005977257-2019-00005
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00190361010586
• UDI-Public: (01)00190361010586(10)DF21
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-80101
• Device Lot Number: DF21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention