MAUDE Adverse Event Report: NEXXT SPINE LLC NEXXT MATRIXX INTERBODY SYSTEM; MATRIXX TLIF OBLIQUE

Model Number	54M-30-12-SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of manufacturing records shows the product was released with no anomalies and conforming to design specifications.As part of risk management, the condition is addressed in the ifu and surgical technique.
Event or Problem Description
It was reported on (b)(6) 2019 that a tlif oblique implant fractured during the insert and rotate technique.The procedure involved the implantation of two tlif oblique cages.One was successful.The surgeon pounded a second 30dx10wx12h tlif oblique implant into a 4mm disc space, increasing the disc space to 10mm to accommodate the interbody.When rotating from 10mm to 12mm orientation, the interbody broke.The surgeon used excessive force to rotate the interbody which exceeded the design limits for rotation.The implant was investigated to be secure, and no pieces broke off or fell into the wound, so it was left in place to perform its intended function.

• Brand Name: NEXXT MATRIXX INTERBODY SYSTEM
• Common Device Name: MATRIXX TLIF OBLIQUE
• Manufacturer (Section D): NEXXT SPINE LLC; 14425 bergen blvd; suite b; noblesville IN 46060
• MDR Report Key: 8430343
• Report Number: 3007922509-2019-00001
• Device Sequence Number: 193499
• Product Code: MQP
• UDI-Device Identifier: 00889929026229
• UDI-Public: 01008899290262291723041010NS8633C
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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 Expiration Date: 04/10/2023
• Device Model Number: 54M-30-12-SP
• Device Catalogue Number: N/A
• Device Lot Number: NS8633C
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 03/18/2019
• 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