MAUDE Adverse Event Report: SEASPINE, INC NORTHSTAR¿ OCT SPINAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	PC1-524055
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report of the rod backing out was confirmed based on films provided to seaspine.The root cause has not been identified as there have been no devices or instruments removed for evaluation.No revision surgery is planned at this time, as the patient declined a revision.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
Observation of films taken post-operatively on (b)(6) " 2921", show rod slippage.The first screw is in the bone; however, the rod is not in the set screw as expected.The rod can be seen below the level of the first screw.There is no indication of the set caps floating.The surgeon states that it was a difficult case with major deformity in the patient, as well as poor bone quality.The patient declines further action.As such, the surgeon will monitor the patient.

• Brand Name: NORTHSTAR¿ OCT SPINAL SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 12999075
• Report Number: 3012120772-2021-00087
• Device Sequence Number: 5262355
• Product Code: NKG
• UDI-Device Identifier: 10889981199036
• UDI-Public: 10889981199036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193615
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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: PC1-524055
• Device Catalogue Number: PC1-524055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NORTHSTAR SET SCREWS, MODEL UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male