MAUDE Adverse Event Report: AESCULAP AG S4 ADJUSTABLE CROSS CONNECTOR 50-60MM; SPINE SURGERY

Model Number	SW496T
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results are received, they will be provided in a supplemental report.
Event or Problem Description
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).
Additional Manufacturer Narrative
Additional information - d4 (udi).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not required.
Event or Problem Description
No changes required.

• Brand Name: S4 ADJUSTABLE CROSS CONNECTOR 50-60MM
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12446831
• Report Number: 2916714-2021-00190
• Device Sequence Number: 11807524
• Product Code: NKB
• UDI-Device Identifier: 04046963144098
• UDI-Public: 4046963144098
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022
• Report Date (Section F): 09/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SW496T
• Device Catalogue Number: SW496T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 08/12/2022
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Date Report Sent to FDA: 09/08/2021