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

Model Number	21M
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The company was informed of a revision case of the tops system in usa.The original procedure was performed on (b)(6), 2021 due to l4-l5 spondylolisthesis and moderate stenosis (lateral recess and foraminal).The patient was treated with tops at l4-l5 as part of the us ide clinical study.In the postoperative period, the patient complained of noise from the implant while bending, yet no other symptoms were reported, and the patient was pain free.However, at 18 months the patient was diagnosed with adjacent level stenosis with some lower extremity discomfort that persisted despite conservative care of the lumbar spine.The combination of device noise, radiographic analysis of the patient and the subject's symptoms led to the recommendation to remove the tops implant and perform a two-level fusion.During the re-operation, it was noted that there was no debris around the tops device and the surrounding tissue was normal in appearance.The tops device, four set screws, and four pedicle screws were removed without incident.The pedicle screws had no evidence of loosening.Six pedicle screws from another manufacturer were placed at l3, l4, and l5 level.Fusion rods and an interbody cage were placed to create a two-level l3-l5 fusion.
Additional Manufacturer Narrative
A review of the manufacturing records of the involved lot was performed and indicated that it was manufactured in accordance with specifications without deviations.At the time of the removal the implants appeared well preserved, and there was no special implant-related observations.The explants were obtained and are awaiting investigation.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.An adjacent level disease which was indicated as a contributing reason for the surgery is known as a common cause of revision after primary spine surgery.Implant noise, that may signal compromise of the articulating mechanism, has been previously reported in a small number of cases.All revision procedures have been performed without sequelae.The cause for the revision surgery in such cases may be multifactorial, including patient and procedure related factors.If additional relevant information becomes available, a follow-up report will be submitted.

• 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: 18910162
• Report Number: 3012401682-2024-00005
• Device Sequence Number: 12484380
• Product Code: QWK
• UDI-Device Identifier: 07290014064010
• UDI-Public: 7290014064010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 03/15/2024

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 Expiration Date: 03/31/2026
• Device Model Number: 21M
• Device Catalogue Number: 85858
• Device Lot Number: RTP0491US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 87 KG