TOPS™ - 21 M 85858Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290014064010), received between Jul 12, 2023 and Jun 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Insufficient Device Problem Information

  THE COMPANY WAS INFORMED OF A REVISION CASE FOR THE TOPS SYSTEM IN THE US. NO INFORMATION WAS PROVIDED REGARDING THE ORIGINAL PROCEDURE. IN THE REVISION SURGERY, THE TOPS MOTION IMPLANT WAS REMOVED AND PATIENT WAS FUSED. THE ORIGINAL SCREWS REMAINED IN-SITU.

  Patient problems: Insufficient Information

  MAUDE report 25536025 ↗
• InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPANY RECEIVED AN EXPLANT FROM A CLINIC IN THE US. NO INFORMATION WAS PROVIDED REGARDING THE REASON FOR DEVICE REMOVAL. NO OTHER DETAILS WERE PROVIDED. THE EXPLANT ARRIVED FOR INVESTIGATION AND WAS EXAMINED.

  Patient problems: Insufficient Information

  MAUDE report 23486405 ↗
• InjuryJun 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE COMPANY RECEIVED AN EXPLANTED DEVICE WHICH WAS REPLACED IN A REVISION CASE OF THE TOPS SYSTEM IN THE US ON (B)(6) 2025. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024. IN THE REVISION SURGERY, THE TOPS MOTION IMPLANT WAS REMOVED AND REPLACED WITH A NEW TOPS DEVICE. THE TOPS EXPLANT WAS RETURNED FOR INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 22304521 ↗
• InjuryJun 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM IN THE US, TO REMOVE AND REINSERT NEW SET SCREWS FOR A PATIENT WHO PREVIOUSLY UNDERWENT TOPS PROCEDURE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT WAS ENGAGED IN INTENSIVE PHYSICAL SPORTS ACTIVITY AND HEARD A POP. SUBSEQUENTLY, THE SURGEON DECIDED TO REPLACE TWO SET SCREWS ON (B)(6) 2025. NO FAILURE IN THE IMPLANTS WAS INDICATED AND ALL THE IMPLANTS REMAINED IN-SITU.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149555 ↗
• InjuryMar 15, 2024Noise, Audible; Noise, Audible

  THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM IN USA. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6), 2021 DUE TO L4-L5 SPONDYLOLISTHESIS AND MODERATE STENOSIS (LATERAL RECESS AND FORAMINAL). THE PATIENT WAS TREATED WITH TOPS AT L4-L5 AS PART OF THE US IDE CLINICAL STUDY. IN THE POSTOPERATIVE PERIOD, THE PATIENT COMPLAINED OF NOISE FROM THE IMPLANT WHILE BENDING, YET NO OTHER SYMPTOMS WERE REPORTED, AND THE PATIENT WAS PAIN FREE. HOWEVER, AT 18 MONTHS THE PATIENT WAS DIAGNOSED WITH ADJACENT LEVEL STENOSIS WITH SOME LOWER EXTREMITY DISCOMFORT THAT PERSISTED DESPITE CONSERVATIVE CARE OF THE LUMBAR SPINE. THE COMBINATION OF DEVICE NOISE, RADIOGRAPHIC ANALYSIS OF THE PATIENT AND THE SUBJECT'S SYMPTOMS LED TO THE RECOMMENDATION TO REMOVE THE TOPS IMPLANT AND PERFORM A TWO-LEVEL FUSION. DURING THE RE-OPERATION, IT WAS NOTED THAT THERE WAS NO DEBRIS AROUND THE TOPS DEVICE AND THE SURROUNDING TISSUE WAS NORMAL IN APPEARANCE. THE TOPS DEVICE, FOUR SET SCREWS, AND FOUR PEDICLE SCREWS WERE REMOVED WITHOUT INCIDENT. THE PEDICLE SCREWS HAD NO EVIDENCE OF LOOSENING. SIX PEDICLE SCREWS FROM ANOTHER MANUFACTURER WERE PLACED AT L3, L4, AND L5 LEVEL. FUSION RODS AND AN INTERBODY CAG

  Patient problems: Pain

  MAUDE report 18910162 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Pain

  MAUDE report 18181425 ↗
• InjuryOct 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED OF A REVISION CASE FOR THE TOPS SYSTEM IMPLANTED TOGETHER WITH VERSALINK IN THE UK. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2022, DUE TO SPONDYLOLISTHESIS WITH SPINAL STENOSIS AND DEGENERATIVE DISC DISEASE AT L4/L5, AND FACET JOINT INSTABILITY WITH LATERAL RECESS STENOSIS AT L5/S1. THE PATIENT WAS TREATED WITH DECOMPRESSION AND TOPS AT L4/L5, AND PLIF CAGES AND VERSALINK AT L5/S1. AFTER A PERIOD, THE PATIENT COMPLAINED OF LOWER BACK PAIN. IN THE REVISION SURGERY, WHICH WAS PERFORMED AFTER ALMOST A YEAR, 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 TOPS EXPLANT HAS BEEN RETURNED AND IS AWAITING INVESTIGATION.

  Patient problems: Pain

  MAUDE report 18026848 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Pain

  MAUDE report 17306120 ↗