S4 SPINAL SYSTEM SW656TRecalls & reported problems
Aesculap AG · S4 PRE-BENT ROD 5.5X45MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653400744), received between Jul 18, 2025 and Jul 18, 2025 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 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 PRE-BENT ROD 5.5X45MM (PART # SW656T) 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)), (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 22540892 ↗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 PRE-BENT ROD 5.5X45MM (PART # SW656T) 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 22540872 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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