MAUDE Adverse Event Report: PREMIA SPINE LTD. TOPS SYSTEM; MOTION-PRESERVING SPINAL IMPLANT

Model Number	21M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lot was performed, and they indicate that the involved lot was manufactured in accordance with company specifications without deviations.A review of the pre-op mri indicates that the patient had a grade 2 spondylolisthesis at l4-l5 and thus not indicated for the tops system.Tops is indicated for up to a grade i spondylolisthesis.Based on the available information, including pre-op imaging and follow-up films, it is believed that the reason for the subsequent surgery was related to the off-label use of the tops which was exacerbated by the surgical reduction performed during the original surgery.The revision was not necessarily related to the tops system.The rate of revisions for the tops system, with or without versalink, is lower than the reported rates in the literature for similar systems.If additional information becomes available, a follow-up report will be submitted.Report submission was delayed due to technical issues.
Event or Problem Description
The company was informed of a revision case for the tops system implanted together with versalink in the uk.The original procedure was performed on (b)(6) 2022, due to spondylolisthesis with spinal stenosis and degenerative disc disease at l4/l5, and facet joint instability with lateral recess stenosis at l5/s1.The patient was treated with decompression and tops at l4/l5, and plif cages and versalink at l5/s1.After a period, the patient complained of lower back pain.In the revision surgery, which was performed after almost a year, the tops motion implant and versalink rods were replaced with two-level fusion rods.The original screws were well fixed in the pedicles and remained in-situ.The tops explant has been returned and is awaiting investigation.

• Brand Name: TOPS SYSTEM
• Common Device Name: MOTION-PRESERVING SPINAL IMPLANT
• Manufacturer (Section D): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer (Section G): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer Contact: elinor limor ; 7 giborey israel st.; ramat poleg; netanya, 42504-07 ; IS 4250407
• MDR Report Key: 18026848
• Report Number: 3012401682-2023-00004
• Device Sequence Number: 12825510
• Product Code: QWK
• UDI-Device Identifier: 07290014064010
• UDI-Public: 7290014064010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2023

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: 21M
• Device Catalogue Number: 85858
• Device Lot Number: RTP0555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female