MAUDE Adverse Event Report: SEASPINE, INC ADMIRAL; CERVICAL PLATE, 2 LEVEL, 30MM

Model Number	AP1-200030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine's admiral plate systems.The index surgery date was on (b)(6) 2022.Seaspine was made aware on (b)(6) 2023 that a screw back out had occurred.The reporter noted that during the index surgery an ap1-200030 cervical plate, 2 level, 30mm was not able to cam lock over the screw to final lock.They only had an issue on one of the distal ends of the plate.During a phone call on (b)(6) 2023 with seaspine, the reporter stated that the surgeon decided to leave the plate in place and completed the index surgery.However, 4 months postop the screw backed out.Then a revision surgery was performed on (b)(6) 2023 to correct the issue.
Additional Manufacturer Narrative
A patient underwent spinal surgery consisting of seaspine's admiral plate systems.The index surgery date was on (b)(6) 2022.Seaspine was made aware on (b)(6) 2023 that a screw back out had occurred.The reporter noted that during the index surgery an ap1-200030 cervical plate, 2 level, 30mm was not able to cam lock over the screw to final lock.They only had an issue on one of the distal ends of the plate.The customer noted that it looks like this plate might have been used before and was put back into the set stripped.This was not confirmed by the engineer's investigation.During a phone call on (b)(6) 2023 with seaspine, the reporter stated that the surgeon decided to leave the plate in place and completed the index surgery.However, 4 months postop the screw backed out.Then a revision surgery was performed on (b)(6) 2023 to correct the issue.The failure analysis performed by seaspine confirmed wear on the locking cover torx.Seaspine was unable to confirm potential use prior to surgery and unable to re-create cam not rotating over the bone screws.The root cause was not determined.Review of labeling (ifu): possible adverse events.Like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis).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.

• Brand Name: ADMIRAL
• Common Device Name: CERVICAL PLATE, 2 LEVEL, 30MM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: robin quiusky ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 16313577
• Report Number: 3012120772-2023-00002
• Device Sequence Number: 20273465
• Product Code: KWQ
• UDI-Device Identifier: 10889981238216
• UDI-Public: 10889981238216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/06/2023

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: AP1-200030
• Device Catalogue Number: AP1-200030
• Device Lot Number: AR88631C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown