MAUDE Adverse Event Report: AESCULAP AG S4 ADJUSTABLE CROSS CONNECTOR 50-60MM; IMPLANTS POSTERIOR STABILISATION

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

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with sw496t - s4 adjustable cross connector 50-60mm.According to the complaint description, the device may have caused an allergic reaction.After lumbar fusion in (b)(6) 2021, a systemic reaction occured postoperatively.It was noted that the only aesculap product involved with 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

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.

• Brand Name: S4 ADJUSTABLE CROSS CONNECTOR 50-60MM
• Type of Device: IMPLANTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12440757
• MDR Text Key: 270364401
• Report Number: 9610612-2021-00617
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG