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

Model Number AP1-210028

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320659270
• Report Number: 3012120772-2023-00015
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10889981278113
• UDI-Public: 10889981278113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP1-210028
• Device Catalogue Number: AP1-210028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female