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

Model Number 34-8109-S

Device Problems Break (1069); Material Fragmentation (1261); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 286498521
• Report Number: 3012120772-2022-00006
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00889981034781
• UDI-Public: 00889981034781
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K210497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 34-8109-S
• Device Catalogue Number: 34-8109-S
• Device Lot Number: BS18C017F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 93-4151 LOT BS16B022F HOLLYWOOD IV INSERTER