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

Model Number	21L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The company was informed of a revision case of the tops system in israel.The original procedure was performed on (b)(6) 2019 due to l3-l4 and l4-l5 spinal stenosis.The patient was treated with tops at l4-l5 and a laminectomy at l3-l4.At some point after the procedure, the patient complained of unresolved pain.As part of the revision surgery, which was performed after more than 4 years, the tops motion implant was removed and the patient was fused l3-l5.According to the surgeon who performed the revision procedure, the reason for the pain was the instability of level l3-l4 due to a wide laminectomy.Neither the tops device nor the l4-l5 segment were the problem.All screws were firmly fixed and used for the fusion procedure.The tops explant was returned for investigation.
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lot was performed and indicated that the involved lot was manufactured in accordance with company specifications without deviations.The explant analysis indicated a level of wear that did not compromise the device's performance.Based on the available information, including explant analysis and imaging of the pre-revision, it is believed that the reason for the subsequent surgery was related to the adjacent level laminectomy performed during the original tops surgery that caused instability at this adjacent segment.It was not related to the tops system.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.Report submission was delayed due to technical issues.

• 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: 18028765
• Report Number: 3012401682-2023-00005
• Device Sequence Number: 6924537
• Product Code: QWK
• UDI-Device Identifier: 07290014064003
• UDI-Public: 7290014064003
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/30/2023

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 Expiration Date: 09/10/2023
• Device Model Number: 21L
• Device Catalogue Number: 82643
• Device Lot Number: RTP0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2018
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male