MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION CABO ANTERIOR CERVICAL PLATE SYSTEM; VARIABLE - 4.0MM SELF TAPPING 16MM

Model Number	81-1216
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Seaspine was made aware of this event on 28 dec 2020.The implant was not made available for review as it remains in-situ; at this time, there is no additional treatment or surgery planned for this patient.The patient is asymptomatic and continues to be monitored by the surgeon for any indication prompting surgical intervention.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
The patient underwent a 2-level anterior cervical spine surgery on (b)(6) 2020 using seaspine's cabo anterior cervical plate system.In a 6-week post operative follow up appointment, imaging revealed a lower screw had loosened.

• Brand Name: CABO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: VARIABLE - 4.0MM SELF TAPPING 16MM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 11208403
• Report Number: 3012120772-2021-00006
• Device Sequence Number: 4759940
• Product Code: KWQ
• UDI-Device Identifier: 10889981160722
• UDI-Public: 10889981160722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 81-1216
• Device Catalogue Number: 81-1216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEASPINE CABO 2-LEVEL PLATE 34MM
• Patient Age: 49 YR