MAUDE Adverse Event Report: SPINEFRONTIER INC. PEDFUSE

Model Number SI80074

Device Problems Mechanical Problem (1384); Component or Accessory Incompatibility (2897)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Spinefrontier investigation into this matter included; a review of the device history record, which revealed that this lot passed all incoming inspection and was released to distribution without any concessions.Complaint trending determine this system was released in 2009, this was the first documented occurrence of this nature therefore the risk classification.Remains acceptable following a review of all risk documentation.A tolerance analysis review establishes that in worst cases there could be a fit issue, this prompted a drawing update to ensure that the device has enough clearance with the implant and the drivers and was subsequently reworked to the new drawing specifications.Spinefrontier is considering it's investigation into this matter closed, no further action is required at this time.

• 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: 8629880
• MDR Text Key: 146495949
• Report Number: 3005977257-2019-00010
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SI80074
• Device Lot Number: CT12E038
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention