MAUDE Adverse Event Report: MARINER PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	41-100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(1 of 4) the incident was received through manufacturer's legal department.No product has been returned, no lot number has been provided, no radiographs received and no further evaluation of the product can be completed at this time.The following medwatch numbers are all related to the same incident: 3012120772-2019-00019 (149017), 3012120772-2019-00020 (149018), 3012120772-2019-00021 (149019).It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's alleged disassociation.Review of labeling notes: possible adverse events: 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.Labeling warnings and precautions: based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions.The root cause of this event cannot be determined at this time.No conclusion can be drawn.
Event or Problem Description
Index surgery occurred on (b)(6) 2017, which included a partial l4-5 decompressive lumbar laminectomy, left l5-s1 microforaminotomy, l4 to s1 pedicle instrumentation and facet fusion.According to the legal document received, bilateral set screws were broken, and rods were bent.It is unknown how the discovery of broken set screws and bent rods were identified, as no images or medical evaluation were provided.According to the legal document received, the patient sustained injuries which resulted in pain, requiring surgical intervention.Revision occurred on (b)(6) 2018, which included removal of manufacturer's fixation system.Current patient condition is unknown.
Additional Manufacturer Narrative
According to the legal document received, bilateral set screws were broken, and rods were bent.It is unknown how the discovery of broken set screws and bent rods were identified, as no images or medical evaluation were provided.According to the legal document received, the patient sustained injuries which resulted in pain, requiring surgical intervention.Revision occurred on (b)(6) 2018, which included removal of manufacturer's fixation system.(1 of 4) the incident was received through manufacturer's legal department.No product has been returned, no lot number has been provided, no radiographs received and no further evaluation of the product can be completed at this time.The following medwatch numbers are all related to the same incident: 3012120772-2019-00019 (149017), 3012120772-2019-00020 (149018), 3012120772-2019-00021 (149019).The root cause appears to be related to patient factors (bleeding) that caused the surgeon to terminate the expected construct; the alternate construct had excessive load placed on fixation components.The patient's inability to fuse also contributed to the high load placed on the initial construct.It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's alleged disassociation.Review of labeling notes: possible adverse events 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.Labeling warnings and precautions: based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions.Revised analysis: revision surgery occurred on (b)(6) 2018 at another facility.Surgeon noted only bilateral s1 screw fractures were present in explanted product.Rod / set screw damage or loosening have not been confirmed.Explants are believed to be in possession of the patient or her agents and have not been made available for further analysis.The initial construct planned was not completed due to unexpected bleeding from bony tissue (described as "fairly continuous bony oozing") unrelated to the seaspine products utilized.Based on the suspicion of undiagnosed bleeding disorder and persistence of the bleeding, interbody devices were not placed to minimize the potential for additional blood loss.Blood loss totaled an estimated 1800ml; no transfusions were noted in the operative notes.The patient was noted to have body mass index 30, indicating obesity.Post-operative diagnosis included an untreated spondylolisthesis.The pseudarthrosis event is not unexpected given the patient-related factors, the incomplete construct that increased the load on the fixation components as well as 6.5mm screws used in sacrum.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 8786991
• Report Number: 3012120772-2019-00022
• Device Sequence Number: 1689544
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41-100
• Device Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 48 YR