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

Model Number	21L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records of the involved lot showed that it was manufactured in accordance with specifications with no deviations.The explants have not been returned for investigation.Misalignment of the tops implant was visible in photos taken during the explanation and in the x-ray taken after the initial surgery.The tops implant was found damaged with signs of wear.The damage could be attributed to the extraction procedure, however no conclusion could be made before the explant is returned and investigated.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 supplemental report will be filed.
Event or Problem Description
The company was informed of a revision case for the tops system implanted together with versalink in germany.The original procedure was performed on (b)(6) 2021, due to spinal stenosis and degenerative disc disease at l5/s1.The patient was treated with decompression and tops at l4/l5, and versalink at l5/s1.After a few months, the patient complained of pain.In the revision surgery, which was performed after more than 2 years, 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 explants have not been returned for 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: 18534168
• Report Number: 3012401682-2024-00001
• Device Sequence Number: 20776736
• Product Code: QWK
• UDI-Device Identifier: 07290014064003
• UDI-Public: 07290014064003
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/18/2024

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: 21L
• Device Catalogue Number: 82643
• Device Lot Number: RTP0492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Weight: 85 KG