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

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	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device failure was indicated in the original procedure or in the explanted device at the time of removal.The explants could not be obtained for investigation.Review of the manufacturing records of the involved lots was performed and indicated that the involved lot was manufactured in accordance with company specifications without deviations.Based on the available information, it is believed that the reason for the subsequent surgery may have been adjacent level disease (ald).Revision surgeries due to ald, are commonly required after primary spine surgery.
Event or Problem Description
The company was informed about a revision case of the tops system in austria due to back pain and increased deformity at the adjacent level (l3-l4).The original procedure was performed on (b)(6) 2017 due to lumbar spinal stenosis, back pain, leg pain, and slight deformity.The tops was implanted at l4-l5.In the revision surgery, which was performed after 6 years, the tops motion implant and pedicle screws were removed and a fusion system was implanted.No failure in the implants or their positioning was indicated.It was reported by the distributor representative who attended the revision surgery that the tops was well fixed inside the screws, and the screws were well fixed in the pedicles before commencing the revision.The implants appeared well preserved after the revision, and there was no special implant-related observations.No images from the revision surgery were available for review.

• Brand Name: TOPS SYSTEM
• Common Device Name: MOTION-PRESERVING SPINAL IMPLANT- PRODUCT CODE - QWK
• 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: 17306120
• Report Number: 3012401682-2023-00002
• Device Sequence Number: 20504384
• Product Code: NQW
• UDI-Device Identifier: 07290014064010
• UDI-Public: 7290014064010
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/12/2023

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: 01/31/2020
• Device Model Number: 21M
• Device Catalogue Number: 85858
• Device Lot Number: RTP0110
• 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: 06/16/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• 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: 72 YR
• Patient Sex: Female