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	07/18/2023
Type of Reportable Event	Serious Injury
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 performance.The findings are aligned with the pre-revision imaging, indicating that the implant was implanted with insufficient intrapedicular distance and was forced into the pedicle screws, which is contrary to the system's surgical technique.Based on the available information, as indicated by the surgeon and since the explant analysis indicated that the tops remained functional, it is believed that the reason for the subsequent surgery was related to the degenerative disease of the patient at the lower level and 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.
Event or Problem Description
The company received an explant from a revision case of the tops system in israel.The original procedure was performed on (b)(6) 2018 due to l3-l4 spinal stenosis and grade 1 spondylolisthesis.The patient was treated with tops at l3-l4.Almost 5 years later, the patient complained of back and leg pain.The patient was diagnosed with spinal stenosis at the level below the index surgery (l4-l5).The surgeon decided to replace the tops with a new identical one and add the versalink fixation system to l4-l5.According to the surgeon who performed the revision procedure, the pain was related to the adjacent level due to progression of the disease.

• 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: 18181425
• Report Number: 3012401682-2023-00006
• Device Sequence Number: 20755075
• Product Code: QWK
• UDI-Device Identifier: 07290014064010
• UDI-Public: 7290014064010
• 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: 2018
• 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): 11/21/2023

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: 05/01/2023
• Device Model Number: 21M
• Device Catalogue Number: 85858
• Device Lot Number: RTP0283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2018
• 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: 77 YR
• Patient Sex: Male