MAUDE Adverse Event Report: SEASPINE, INC MARINER; SET SCREW

Model Number	41-1010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the revision case the surgeon removed all of the old lumbar screws (mirus) shown in the pre-op.Although seapine's fenestrated screws are not indicated with cement, the surgeon made the decision to implant the fenestrated screws at t10 & t11 and injected them with cement.The surgeon skipped t12 because of the prior kyphoplasty that was done.He performed a pso at l1/l2 which had fused together in kyphosis.For this reason, he was only able to get screws in at l1 but not l2.He placed cannulated screws at l3, and fenestrated screws at l4.We had some challenges with the consistency of the cement at t10 & t11 and he chose not to use cement at l4.He used the mazor-x robot to pre-plan and drill the trajectory for all screws.The update below was provided by a seaspine representative regarding the revision surgery performed on (b)(6) 2022: the revision for the patient was (b)(6) 2022 in the afternoon.The case went well.We left the existing screws, but removed the rods, crosslink and all set screws.We added new screws at the bottom of the construct, we added four 6.0 rods with rod to rod connectors, and replaced all set screws.Additionally, he surgeon performed a tlif at l5-s1.Labeling states that this is an inherent rist of using this system.
Event or Problem Description
Seaspine was made aware of an event involving multiple set screws loosening post-operatively.The index surgery was on (b)(6) 2022 and the event date is on (b)(6) 2022 there were 10 screws over 6 lots involved and are as follows: product lot number product quantity aw155418d 4, aw154141d 2, aw132005d 1, aw147643d 1, aw154681d 1, aw154138d 1.This patient had a prior fusion from l2-l4.They had a previous fracture at t12 which was cemented.They kyphosed above their hardware at l1.L1 and l2 subsequently fused together.If i remember correctly[?]they also had some cervical work down that's not shown.

• Brand Name: MARINER
• Common Device Name: SET SCREW
• 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 dr.; carlsbad, CA 92008
• MDR Report Key: 16039921
• Report Number: 3012120772-2022-00057
• Device Sequence Number: 17708794
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/22/2022

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: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown