AESCULAP SW496TRecalls & reported problems

Aesculap AG · S4 ADJUSTABLE CROSS CONNECTOR 50-60MM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963144098), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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

Device problems

Device Appears to Trigger Rejection1

Patient problems

Hypersensitivity/Allergic reaction1
Implant Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN S4 ADJUSTABLE CROSS CONNECTOR. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE MAY HAVE CAUSED AN ALLERGIC REACTION. AFTER LUMBAR FUSION IN (B)(6) 2021, A SYSTEMIC REACTION OCCURED SOMETIME POSTOPERATIVELY. IT WAS NOTED THAT THE ONLY AESCULAP PRODUCT IMPLANTED IN THE ORIGINAL SURGERY WAS A CROSSLINKER, SW496T. THIS EVENT CAUSED AN IMPAIRMENT (UNSPECIFIED SYMPTOMS). ADDITIONAL INFORMATION WAS NOT PROVIDED. . THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Hypersensitivity/Allergic reaction; Implant Pain
MAUDE report 12446831 ↗

Device details

UDI-DI	`04046963144098`
Brand	AESCULAP
Model	SW496T
Company	Aesculap AG
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Nov 13, 2025

Device type (GMDN): Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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