MAUDE Adverse Event Report: SPINEFRONTIER, INC PEDFUSE

Model Number 0180101

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

The incident reported under this report, stated a follow up x-ray for an l5-s1 fusion showed that the ø5-7 mm set screw (01-80101, lot# be08a) had backed out of the right inferior (l5) pedicle screw tulip (part#: 02-80081-02 lot# 8603), a sub-component of the pedicle screw assembly (part#: 01-80169-45r lot#: 273m) and was free floating in the soft tissue.As a second note the p-lift cage had migrated posteriorly.This is the second of 2 occurrences involving a set screw backing out of a pedicle screw assembly in the same patient, the other occurrence was reported under mdr #: 3005977257-2016-00005.Based on the known factors of the surgical event, the surgery was performed in compliance with spinefrontier's surgical techniques and ifu.The ø5-7 mm set screw part #: 01-80101, lot #: be08a inspection data shows that the set screw conforms to the drawing and all parts from the construct passed functional fit checks.The risk management files associated with the device had shown that this failure mode had been analyzed and was rated alarp with an occasional occurrence, which is in line with what has occurred.Spinefrontier mitigated the risk as low as reasonably possible and all supporting mitigations were in place and sufficient.In conclusion, this is an event that may happen with an occasional occurrence and does not warrant any further action.The other component associated with this event (pedicle screw tulip assembly part#: 01-80169-45r lot#: 273m) was reported under mdr #: 3005977257-2016-00004.

Event Description

A spinefrontier representative stated that a follow-up x-ray revealed that the set screw had backed out of right inferior (l5) tulip in a patient who underwent l5-s1 fusion revision surgery.The set screw was free floating in soft tissue and the cage had migrated posteriorly.The patients age, weight, height, relevant or pre-existing medical conditions, medication, pre-operative x-rays/mri, post-operative x-rays/mri, post-operative activities, and any event that may have lead up to the set screw backing out were requested but are unknown.This is the second revision surgery to replace the set screw and the tulip.The first revision surgery for the set screw backing out of (s1) tulip was reported under mdr #: 3005977257-2016-00005.

• Brand Name: PEDFUSE
• Type of Device: PEDFUSE
• Manufacturer (Section D): SPINEFRONTIER, INC; 350 main st; third floor; malden MA 02148
• Manufacturer (Section G): SPINEFRONTIER, INC; 350 main st; third floor; malden MA 02148
• Manufacturer Contact: josh harkess ; 350 main st; third floor; malden, MA 02148 ; 9782323990
• MDR Report Key: 6955057
• MDR Text Key: 90559182
• Report Number: 3005977257-2016-00006
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K092420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 02/24/2016

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
• Device Operator: Physician
• Device Model Number: 0180101
• Device Lot Number: BE08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention