MAUDE Adverse Event Report: SPINEFRONTIER INC PEDFUSE; PEDICLE SET SCREW

Model Number	01-80101
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The acual set screw involved in this occurrence was not evaluated, however, this occurrence was evaluated by the design and development product manager overseeing the pedfuse project.Spinefrontier investigation into this matter determined that the failure was most likely due to user related factors (cross threading) which allowed for some of the distal set screw thread to shear off.There is also a potential that the user should have used a reducer as outline in the pedfuse surgical technique to compensate for any issues relating to the rod not been fully reduced in the tulip, conditions such as these would have made it difficult to insert the locking cap therefore leading to cross threading.A review of the pedfuse system labeling determined adequate warnings against cross threading was considered and in alignment with the current risk mitigation's, in light of this, no further actions are necessary at this time.
Event or Problem Description
On (b)(6) 2018, it was reported that the pedfuse reset locking caps shed a strip of metal while tightening during surgery.

• Brand Name: PEDFUSE
• Common Device Name: PEDICLE SET SCREW
• Manufacturer (Section D): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• MDR Report Key: 8638695
• Report Number: 3005977257-2019-00008
• Device Sequence Number: 13908680
• Product Code: MNH
• UDI-Device Identifier: 00190361010586
• UDI-Public: (01)00190361010586(10)DL20B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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 Catalogue Number: N/A
• Device Lot Number: DL20B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention