4WEB Medical PSTS-SM0609-26-SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812998022519), received between Jun 23, 2020 and Jun 23, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2020Migration; Migration

  DURING THE SIX MONTHS FOLLOW-UP AFTER THE ORIGINAL SURGERY INVOLVING L5-S1, THE SURGEON IDENTIFIED THAT ONE OF THE THREE IMPLANTED CAGES HAD MIGRATED INTO THE CANAL. THE PATIENT ALSO REPORTED PAIN. THE SURGEON PERFORMED A REVISION SURGERY TO IMPACT THE CAGE DEEPER INTO THE DISC SPACE SINCE THE IMPLANT COULD NOT BE SAFELY REMOVED. IT IS UNKNOWN WHICH OF THE THREE IMPLANTED CAGES IS RELATED TO THE REPORTED INCIDENT. THEREFORE, ALL THREE DEVICES ARE BEING REPORTED (DEVICE 2 OF 3).

  Patient problems: Pain

  MAUDE report 10186665 ↗
• InjuryJun 23, 2020Migration; Migration

  DURING THE SIX MONTHS FOLLOW-UP AFTER THE ORIGINAL SURGERY INVOLVING L5-S1, THE SURGEON IDENTIFIED THAT ONE OF THE THREE IMPLANTED CAGE HAD MIGRATED INTO THE CANAL. THE PATIENT ALSO REPORTED PAIN. THE SURGEON PERFORMED A REVISION SURGERY TO IMPACT THE CAGE DEEPER INTO THE DISC SPACE SINCE THE IMPLANT COULD NOT BE SAFELY REMOVED. IT IS UNKNOWN WHICH OF THE THREE IMPLANTED CAGES IS RELATED TO THE REPORTED INCIDENT. THEREFORE, ALL THREE DEVICES ARE BEING REPORTED (DEVICE 1 OF 3).

  Patient problems: Pain

  MAUDE report 10186639 ↗
• InjuryJun 23, 2020Migration; Migration

  DURING THE SIX MONTHS FOLLOW-UP AFTER THE ORIGINAL SURGERY INVOLVING L5-S1, THE SURGEON IDENTIFIED THAT ONE OF THE THREE IMPLANTED CAGES HAD MIGRATED INTO THE CANAL. THE PATIENT ALSO REPORTED PAIN. THE SURGEON PERFORMED A REVISION SURGERY TO IMPACT THE CAGE DEEPER INTO THE DISC SPACE SINCE THE IMPLANT COULD NOT BE SAFELY REMOVED. IT IS UNKNOWN WHICH OF THE THREE IMPLANTED CAGES IS RELATED TO THE REPORTED INCIDENT. THEREFORE, ALL THREE DEVICES ARE BEING REPORTED (DEVICE 3 OF 3).

  Patient problems: Pain

  MAUDE report 10186631 ↗
• InjuryJun 23, 2020Migration; Migration

  DURING SIX-WEEK POST-OP FOLLOW-UP AFTER THE ORIGINAL SURGERY L5-S1, THE SURGEON IDENTIFIED THAT ONE OF TWO IMPLANTED CAGES HAD MIGRATED INTO THE CANAL. THE PATIENT ALSO REPORTED PAIN. THE SURGEON PERFORMED A REVISION SURGERY TO EXPLANT THE CAGE. IT IS UNKNOWN WHICH OF THE TWO IMPLANTED CAGES IS RELATED TO THE REPORTED INCIDENT. THEREFORE, BOTH THE DEVICES ARE BEING REPORTED (DEVICE 1 OF 2).

  Patient problems: Pain

  MAUDE report 10186630 ↗
• InjuryJun 23, 2020Migration; Migration

  ABOUT TWO AND A HALF MONTHS FOLLOWING THE ORIGINAL SURGERY INVOLVING L3-4 AND L4-5, THE PATIENT REPORTED PAIN. THE SURGEON INDICATED THAT THE CAGE MIGRATED INTO THE CANAL. AS A RESULT, HE PERFORMED A REVISION SURGERY TO IMPACT BOTH CAGES DEEPER INTO THE ANTERIOR DISC SPACE. IT IS UNKNOWN WHICH DEVICE IS RELATED TO THE REPORTED INCIDENT. THEREFORE, BOTH DEVICES ARE BEING REPORTED (DEVICE 2 OF 2).

  Patient problems: Pain

  MAUDE report 10186598 ↗
• InjuryJun 23, 2020Migration; Migration

  ABOUT TWO AND A HALF MONTHS FOLLOWING THE ORIGINAL SURGERY INVOLVING L3-4 AND L4-5, THE PATIENT REPORTED PAIN. THE SURGEON INDICATED THAT THE CAGE MIGRATED INTO THE CANAL. AS A RESULT, HE PERFORMED A REVISION SURGERY TO IMPACT BOTH CAGES DEEPER INTO THE ANTERIOR DISC SPACE. IT IS UNKNOWN WHICH DEVICE IS RELATED TO THE REPORTED INCIDENT. THEREFORE, BOTH DEVICES ARE BEING REPORTED (DEVICE 1 OF 2).

  Patient problems: Pain

  MAUDE report 10186415 ↗