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

Model Number	54M-26-08-SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of manufacturing history 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) 2018 during a spinal procedure a matrixx implant fractured while the surgeon was trying to rotate into placement.The surgeon was pushing the implant beyond expectation and caused an extreme load and the implant fractured.It should be noted, the torque applied to the implant was greater than the design limit.75% to 80% of the device is implanted in the disc space and the remainder of the device was not implanted as it was attached to the inserting instrument.At no time during the procedure, did a fractured piece fall into the patient's wound.The surgeon investigated and found the implant to be secure and was performing as intended so it was decided to leave the implant in place.There was no patient injury due to the event.The remainder of the implant was lost by the central processing center at the hostpital and will not be returned to nexxt spine.

• 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: 7984992
• Report Number: 3007922509-2018-00001
• Device Sequence Number: 1681906
• Product Code: MQP
• UDI-Device Identifier: 00889929020258
• UDI-Public: 00889929020258
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 09/26/2022
• Device Model Number: 54M-26-08-SP
• Device Lot Number: NS7729A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 10/19/2018
• 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
• Patient Age: 48 YR