MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL ACP SYSTEM; AP1-210028 CERVICAL PLATE, 2 LEVEL, 28MM

Model Number	AP1-210028
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2023, it was reported that a surgeon experienced difficulty during an acdf c5-c7 performed on (b)(6)2023 with the locking mechanism on an ap1-210028 cervical plate, 2 level, 28mm.No explants will be returned.The surgeon bent the plate but not over the locking mechanism.The surgeon was able to lock c5 and c7 but c6 spun freely with no resistance when turning the cover.It was observed that the cover was not sitting proud.
Additional Manufacturer Narrative
On (b)(6)2023, it was reported that a surgeon experienced difficulty during an acdf c5-c7 performed on (b)(6)2023 with the locking mechanism on an ap1-210028 cervical plate, 2 level, 28mm.No explants will be returned.The surgeon bent the plate but not over the locking mechanism.The surgeon was able to lock c5 and c7 but c6 spun freely with no resistance when turning the cover.It was observed that the cover was not sitting proud.There was no device returned for evaluation, as the device remained in the patient.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) bending, disassembly, or fracture of implant and components, 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 ACP SYSTEM
• Common Device Name: AP1-210028 CERVICAL PLATE, 2 LEVEL, 28MM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad 92008
• Manufacturer Contact: taara maharaj ; 5770 armada dr.; carlsbad 92008
• MDR Report Key: 17484737
• Report Number: 3012120772-2023-00015
• Device Sequence Number: 17955143
• Product Code: KWQ
• UDI-Device Identifier: 10889981278113
• UDI-Public: 10889981278113
• 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: 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): 08/08/2023

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: AP1-210028
• Device Catalogue Number: AP1-210028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female