TOPS SYSTEM
Report
- Report Number
- 3012401682-2025-00014
- Event Type
- Injury
- Date Received
- November 26, 2025
- Date of Event
- October 27, 2025
- Report Date
- January 20, 2026
- Manufacturer
- PREMIA SPINE LTD.
- Product Code
- QWK
- UDI-DI
- 07290014064034
- PMA / PMN Number
- P220002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE EXPLANT ANALYSIS IDENTIFIED WEAR OF THE IMPLANT'S INTERNAL COMPONENTS. THE ROOT CAUSE OF THE OBSERVED WEAR COULD NOT BE CONCLUSIVELY DETERMINED. REVISIONS ASSOCIATED WITH SIGNS OF WEAR HAVE BEEN PREVIOUSLY REPORTED IN A SMALL NUMBER OF CASES WITHOUT ANY SEQUELAE. THE CAUSE FOR THE REVISION SURGERY IN SUCH CASES MAY BE MULTIFACTORIAL, INVOLVING PATIENT AND PROCEDURE RELATED FACTORS. THUS, IN THE PRESENT CASE, IT IS PRESUMED THAT A COMBINATION OF FACTORS, INCLUDING PATIENT ANATOMY, SURGICAL TECHNIQUE, AND A HIGH LEVEL OF PHYSICAL ACTIVITY MAY HAVE CONTRIBUTED TO THE WEAR.
REVIEW OF THE MANUFACTURING RECORDS OF THE INVOLVED LOT WAS PERFORMED AND INDICATED THAT IT WAS MANUFACTURED IN ACCORDANCE WITH COMPANY SPECIFICATIONS WITHOUT DEVIATIONS. THE EXPLANT WAS OBTAINED AND IS AWAITING INVESTIGATION. IMPLANT NOISE, THAT MAY BE RELATED TO THE ARTICULATING MECHANISM, HAS BEEN PREVIOUSLY REPORTED IN A SMALL NUMBER OF CASES WHERE THE IMPLANT WAS REVISED, WITHOUT ANY SEQUELAE. THE CAUSE FOR THE REVISION SURGERY IN SUCH CASES MAY BE MULTIFACTORIAL, INCLUDING PATIENT AND PROCEDURE RELATED FACTORS. THE RATE OF REVISIONS FOR THE TOPS SYSTEM IS LOWER THAN THE REPORTED RATES IN THE LITERATURE FOR SIMILAR SYSTEMS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE UPON COMPLETION OF EXPLANT INVESTIGATION.
THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN ISRAEL. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO SPINAL STENOSIS WITH GRADE I SPONDYLOLISTHESIS. THE PATIENT WAS TREATED WITH TOPS AT L4-L5. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2022 DUE TO PAIN AND INSTABILITY DISCOVERED IN THE INDEX LEVEL. THE PATIENT RECENTLY COMPLAINED OF PAIN AND NOISE DURING MOVEMENT, AND ON (B)(6) 2025, THE TOPS MOTION IMPLANT WAS REMOVED AND REPLACED WITH A NEW TOPS DEVICE AS PART OF A 2ND REVISION SURGERY. THE TOPS EXPLANT WAS RETURNED FOR INVESTIGATION.
THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN ISRAEL. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO SPINAL STENOSIS WITH GRADE I SPONDYLOLISTHESIS. THE PATIENT WAS TREATED WITH TOPS AT L4-L5. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2022 DUE TO PAIN AND INSTABILITY DISCOVERED IN THE INDEX LEVEL. THE PATIENT RECENTLY COMPLAINED OF PAIN AND NOISE DURING MOVEMENT, AND ON (B)(6) 2025, THE TOPS MOTION IMPLANT WAS REMOVED AND REPLACED WITH A NEW TOPS DEVICE AS PART OF A 2ND REVISION SURGERY. THE TOPS EXPLANT WAS RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2568825 | TOPS SYSTEM | MOTION-PRESERVING SPINAL IMPLANT | QWK | PREMIA SPINE LTD. | 30L | RTP0419 | 07290014064034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |