MAUDE Adverse Event Report: SPINEFRONTIER INC. PEDFUSE

Model Number	01-80101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PEDFUSE
• Manufacturer (Section D): SPINEFRONTIER INC.; 350 main st; second floor; malden MA 02148
• MDR Report Key: 8622112
• Report Number: 3005977257-2019-00005
• Device Sequence Number: 10837346
• Product Code: MNH
• UDI-Device Identifier: 00190361010586
• UDI-Public: (01)00190361010586(10)DF21
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention