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

Model Number	30M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No failure was indicated in the original procedure or in the explant at the time of revision.Explant was not returned for investigation and no additional information about the revision is available at this time.Review of the device history records of the involved lot showed that it was manufactured in accordance with specifications with no deviations.Based on the available information the reason for the revision surgery and whether it is related to the tops could not be determined.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
The company was informed about a revision case of the tops system in france.The original procedure was performed on (b)(6) 2022.In the revision surgery, which was performed after more than a year, the tops motion implant was removed and replaced with a new one.No other details were provided and no additional information is available.

• 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: 18441900
• Report Number: 3012401682-2023-00008
• Device Sequence Number: 6883735
• Product Code: QWK
• UDI-Device Identifier: 07290014064041
• UDI-Public: 7290014064041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/04/2024

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 Model Number: 30M
• Device Catalogue Number: 85859
• Device Lot Number: RTP0576
• 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: 12/07/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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: Unknown