MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE REGATTA LATERAL SYSTEM; LATERAL IMPLANT, 18MM X 14MM X 55MM, 15°

Model Number	36-181455-15
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No explants were made available for analysis.However, review of the provided x-ray confirmed the reported failure.The surgeon stated that the patient is "doing ok," and there is no known revision plan.Review of labeling: possible adverse events: 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.
Event or Problem Description
On (b)(6) 2022 a patient underwent spinal surgery utilizing seaspine's regatta interbody and plate systems.On 15 sep 2022, seaspine was made aware that the interbody migrated three weeks post-operatively.The reported failure was confirmed via provided x-ray.
Additional Manufacturer Narrative
No explants were made available for analysis.However, review of the provided x-ray confirmed the reported failure.The surgeon stated that the patient is "doing ok," and there is no known revision plan.Review of labeling: possible adverse events 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.
Event or Problem Description
This supplemental is being filed to include the udi number that was available, but not included in the initial report.On (b)(6) 2022 a patient underwent spinal surgery utilizing seaspine's regatta interbody and plate systems.On 15 sep 2022, seaspine was made aware that the interbody migrated three weeks post-operatively.The reported failure was confirmed via provided x-ray.

• Brand Name: SEASPINE REGATTA LATERAL SYSTEM
• Common Device Name: LATERAL IMPLANT, 18MM X 14MM X 55MM, 15°
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15546619
• Report Number: 3012120772-2022-00043
• Device Sequence Number: 1870033
• Product Code: MAX
• UDI-Device Identifier: 10889981158552
• UDI-Public: 10889981158552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K20119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 36-181455-15
• Device Catalogue Number: 36-181455-15
• Device Lot Number: BS18F021A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 08/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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; Hospitalization
• Patient Sex: Unknown