MAUDE Adverse Event Report: AESCULAP AG S4 SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	SW656T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
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)).
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: S4 SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 22540872
• Report Number: 3005673311-2025-00076
• Device Sequence Number: 7217891
• Product Code: MNI
• UDI-Device Identifier: 04038653400744
• UDI-Public: (01)04038653400744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SW656T
• Device Catalogue Number: SW656T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/18/2025