MAUDE Adverse Event Report: SPINEFRONTIER INC INVUE

Model Number	IM71059-03
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual screw involved in this complaint was successfully implanted, despite the thin strip of the screw threads rubbing off the plate during insertion.This precluded evaluation of the actual sample.Spinefrontier investigation determined this was an extreme lordosis case which required bending the plate to fixate it and screw construct onto the vertebral body.The extreme angulation caused the screw angle of insertion to be outside of the recommended 14° variable screw angulation.When this occurred, it caused an undesired rubbing of the screw on the plate during insertion.The thin flexible strip of the screw thread was removed from the site.This event did not cause harm to the patient and the integrity of the construct was not compromised by this event.A review of the invue max + inset anterior cervical plate dfmea determined that this failure mode shearing of "metal" was identified during the design verification testing, and the risks were adequately mitigated in risk hazard analysis.Complaint vs sales trending identified seven (7) complaints (including this occurrence) of this issue.This occurrence level was calculated at (b)(4), which is a lower occurrence than the range specified by the risk hazard analysis (b)(4) (improbable).Therefore, no risk document does not need to be updated in response to this complaint.A review of the invue max + inset anterior cervical plate ifu-71-00001 and surgical technique st-71-00001 showed both include a warning of shearing in the warnings and precautions sections.
Event or Problem Description
Spinefrontier sales representative reported that during extreme, 4 level lordosis case, the surgeon had to bend the invue plate to conform to the extreme (c5 - c7) lordosis.The angulation of the screw was greater than the recommended 14° variable screw angulation outlined in the surgical technique.The extreme angulation led to a thin flexible strip of the screw threads was rubbed off by the plate.The surgeon removed the thin piece of metal from the surgical site and completed the case without any complications or patient injury.

• Brand Name: INVUE
• Common Device Name: INVUE
• Manufacturer (Section D): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• MDR Report Key: 9056585
• Report Number: 3005977257-2019-00012
• Device Sequence Number: 1849656
• Product Code: KWQ
• UDI-Device Identifier: 00190361002130
• UDI-Public: (01)00190361002130(10)EG16
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: IM71059-03
• Device Catalogue Number: N/A
• Device Lot Number: EG16
• Was Device Available for Evaluation?: No
• Device Age: 9 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/14/2019
• 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