S4 SPINAL SYSTEM SW790TRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04038653455256), received between Sep 17, 2020 and Jul 18, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A S4 SET SCREW NEW VERSION (PART # SW790T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE IMPLANTS WERE TO BE REMOVED DURING A REVISION SURGERY. THE PATIENT HAD FULLY FUSED AND ANATOMY HAD FULLY HEALED. THE SURGEON AND PATIENT AGREED ON THE S4 LUMBAR PEDICLE SYSTEM REMOVAL. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NOTHING WRONG WITH ANY OF THE DEVICES, BUT THAT THE PATIENT WAS FULLY FUSED AND AS THEIR ANATOMY HAD HEALED AND FUSED AS EXPECTED, THE SURGEON WANTED TO REMOVE THE SCREWS. ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00073 (B)(4). 3005673311-2025-00074 (B)(4). 3005673311-2025-00075 (B)(4). 3005673311-2025-00076 (B)(4). 3005673311-2025-00077 (B)(4). 3005673311-2025-00078 (B)(4). 3005673311-2025-00079 (B)(4). 3005673311-2025-00081 (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 22540894 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A S4 SET SCREW NEW VERSION (PART # SW790T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE IMPLANTS WERE TO BE REMOVED DURING A REVISION SURGERY. THE PATIENT HAD FULLY FUSED AND ANATOMY HAD FULLY HEALED. THE SURGEON AND PATIENT AGREED ON THE S4 LUMBAR PEDICLE SYSTEM REMOVAL. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NOTHING WRONG WITH ANY OF THE DEVICES, BUT THAT THE PATIENT WAS FULLY FUSED AND AS THEIR ANATOMY HAD HEALED AND FUSED AS EXPECTED, THE SURGEON WANTED TO REMOVE THE SCREWS. ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00073 (B)(4). 3005673311-2025-00074 (B)(4). 3005673311-2025-00075 (B)(4). 3005673311-2025-00076 (B)(4). 3005673311-2025-00077 (B)(4). 3005673311-2025-00078 (B)(4). 3005673311-2025-00079 (B)(4). 3005673311-2025-00080(B)(4).

  Patient problems: Failure of Implant

  MAUDE report 22540893 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A S4 SET SCREW NEW VERSION (PART # SW790T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE IMPLANTS WERE TO BE REMOVED DURING A REVISION SURGERY. THE PATIENT HAD FULLY FUSED AND ANATOMY HAD FULLY HEALED. THE SURGEON AND PATIENT AGREED ON THE S4 LUMBAR PEDICLE SYSTEM REMOVAL. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NOTHING WRONG WITH ANY OF THE DEVICES, BUT THAT THE PATIENT WAS FULLY FUSED AND AS THEIR ANATOMY HAD HEALED AND FUSED AS EXPECTED, THE SURGEON WANTED TO REMOVE THE SCREWS. ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00073 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00074 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00075 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00076 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00077 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00078 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00079 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00080 (AIC REFERENCE NO. (B)(4), 3005673311-2025-00081 (AIC REFERENCE NO. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 22540891 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A S4 SET SCREW NEW VERSION (PART # SW790T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE IMPLANTS WERE TO BE REMOVED DURING A REVISION SURGERY. THE PATIENT HAD FULLY FUSED AND ANATOMY HAD FULLY HEALED. THE SURGEON AND PATIENT AGREED ON THE S4 LUMBAR PEDICLE SYSTEM REMOVAL. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NOTHING WRONG WITH ANY OF THE DEVICES, BUT THAT THE PATIENT WAS FULLY FUSED AND AS THEIR ANATOMY HAD HEALED AND FUSED AS EXPECTED, THE SURGEON WANTED TO REMOVE THE SCREWS. ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00073 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00074 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00075 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00076 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00077 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00078 (AIC REFERENCE NO. (B)(4)). (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00080 (AIC REFERENCE NO. (B)(4)). 3005673311-2025-00081 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 22540890 ↗
• InjuryAug 2, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW790T - S4 SET SCREW NEW VERSION. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS AN OPERATIVE BREAKAGE OF SET SCREW. THE SET SCREW WAS DAMAGED WHEN THE SET SCREW WAS FASTENED. THE THREAD OF THE SET SCREW WAS DAMAGED AND THE DEBRIS WAS RECOVERED. THE CUSTOMER REPLACED IT WITH A NEW SET SCREW AND WAS ABLE TO FASTEN IT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12258884 ↗
• InjuryMay 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW790T - S4 SET SCREW NEW VERSION. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INITIAL SURGERY WAS (B)(6) 2011. L4 / 5 WAS FIXED USING S4. SINCE NEUROPATHY DUE TO UPPER ADJACENT INTERVERTEBRAL DISORDER OCCURRED, RE-SURGERY WAS PLANNED. AT THAT TIME, IT WAS DISCOVERED THAT THE SET SCREW ON THE RIGHT SIDE OF L4 HAD SLIPPED OFF. THE REVISION WAS PERFORMED ON (B)(6) 2021. FOUR SET SCREWS WERE REMOVED, THE SCREW ON THE RIGHT SIDE OF L4 WAS REMOVED, AND THE SCREWS WERE EXTENDED UP AND DOWN (L3, S1) FOR RE-FIXING. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THIS MATTER IS NOT RELATED TO RE-SURGERY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00398 ((B)(4)+ SW677T), 9610612-2021-00396 ((B)(4)+ SW777T).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11842046 ↗
• MalfunctionSep 17, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A S4 SET SCREW WAS BEING USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE SLIPPED THE THREAD WHILE BEING SCREWED TO LOCK. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10548002 ↗