MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE SPACER SYSTEM - HOLLYWOOD VI NANOMETALENE; VERTEBRAK BODY PROSTHESIS

Model Number	34-8109-S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an implant broke upon impaction during a procedure and a fragment was observed outside of the vertebral area and was not retrieved.
Additional Manufacturer Narrative
It was reported that an implant broke upon impaction.Later it was discovered that a fragment, outside of the vertebral area was left behind.The patient and fragment will be monitored to see if a follow up surgery will be necessary.At the time of this report, follow up surgery has not occurred or been planned for the patient.Review of labeling: possible adverse events: like other spinal system implants, the following adverse events are possible.Bending, disassembly or fracture of implant and components pain, discomfort, or abnormal sensations due to the presence of the device.Intraoperative fissure, fracture, or perforation of the spine.

• Brand Name: SEASPINE SPACER SYSTEM - HOLLYWOOD VI NANOMETALENE
• Common Device Name: VERTEBRAK BODY PROSTHESIS
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13659300
• Report Number: 3012120772-2022-00006
• Device Sequence Number: 1905860
• Product Code: MAX
• UDI-Device Identifier: 00889981034781
• UDI-Public: 00889981034781
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K210497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 34-8109-S
• Device Catalogue Number: 34-8109-S
• Device Lot Number: BS18C017F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 93-4151 LOT BS16B022F HOLLYWOOD IV INSERTER
• Patient Sex: Unknown