MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE SPACER SYSTEM - HOLLYWOOD NANOMETALENE; HOLLYWOOD VI NM IMPLANT, 11X27X14,8 DEG, STERILE

Model Number	34-8114-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient injury and clinical circumstances did not warrant medical intervention; the surgery was completed successfully with an alternative implant.The suspect medical device was returned for analysis.Visual inspection confirmed the proximal end of the implant was sheared at various angles at the extrusions where the inserter mate with the implant, indicating the cause of the fracture is due to mechanical failure under shear stress upon insertion.Review of labeling: possible adverse events.Bending, disassembly or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery on (b)(6) 2021 consisting of seaspine's hollywood nanometalene interbody system.It was reported that the interbody fractured during insertion and the cage turned and became stuck in the disc space.The surgeon was able to recover the implant; however, the reporter was not able to confirm that all fragments were retrieved.

• Brand Name: SEASPINE SPACER SYSTEM - HOLLYWOOD NANOMETALENE
• Common Device Name: HOLLYWOOD VI NM IMPLANT, 11X27X14,8 DEG, STERILE
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11943784
• Report Number: 3012120772-2021-00051
• Device Sequence Number: 17248394
• Product Code: MAX
• UDI-Device Identifier: 00889981034835
• UDI-Public: 00889981034835
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 34-8114-S
• Device Catalogue Number: 34-8114-S
• Device Lot Number: SM010A-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/05/2021
• 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: Other