MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION VU APOD PRIME NANOMETALENE IBD; PRIME NM STERILE ASSY, 35X27MM X 14MM, 10 DEG

Model Number	35-57-1410
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event has been evaluated along with sterilization records and pre-sterilization bioburden management.The minimum sterility assurance level of 10-6 has been achieved and the cause does not appear to be related to manufacturing.
Event or Problem Description
A total of four infection events have been reported in four patients utilizing alif surgical approach and seaspine vu a·pod¿ prime nm product family.Three of four patients received a single-level surgery; the fourth patient underwent a two-level procedure.Non-specific patient identifiers and index surgery dates have been provided.All patients were reported to have subsequently undergone reoperation consisting of surgical site debridement followed by antibiotic treatment.Culture results and sensitivity are not known.Other potentially pertinent patient characteristics such as comorbidities, prior surgical history and extent of index surgery are not known (e.G., additional stabilization).Related submissions: 3012120772-2021-00023, 3012120772-2021-00024, 3012120772-2021-00025.

• Brand Name: VU APOD PRIME NANOMETALENE IBD
• Common Device Name: PRIME NM STERILE ASSY, 35X27MM X 14MM, 10 DEG
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11516129
• Report Number: 3012120772-2021-00026
• Device Sequence Number: 3828446
• Product Code: MAX
• UDI-Device Identifier: 10889981126582
• UDI-Public: 10889981126582
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 35-57-1410
• Device Catalogue Number: 35-57-1410
• Device Lot Number: AU1076268C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/18/2021
• 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: Required Intervention