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

Model Number SW496T

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results are received, they will be provided in a supplemental report.

Event 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).

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 Description

No changes required.

• Brand Name: S4 ADJUSTABLE CROSS CONNECTOR 50-60MM
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12446831
• MDR Text Key: 270698947
• Report Number: 2916714-2021-00190
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046963144098
• UDI-Public: 4046963144098
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2021,08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW496T
• Device Catalogue Number: SW496T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Distributor Facility Aware Date: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG