MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS SPINE ANTERIOR STABILIS.; SPINE SURGERY

Model Number AE-QAS-SP42

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Neuropathy (1983)

Event Type  malfunction  

Event Description

It was reported that there was an issue with an unknown activl device via information from the 2020 ess surgeon survey; however a specific form was not provided.According to the complainant, a sensory neurological event was observed postoperatively at vertebrae l4-l5 and l5-s1.The initial surgery was total disc replacement (tdr) with implantation of spike endplate.The physician noted "transient numbness" and "paresthesias".There was temporary impairment.No further patient details are currently available.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 a lot number was not provided, the device quality and manufacturing history records could not be checked.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 on the investigation results, a capa is not necessary.

• Brand Name: COLLECT.NO.QAS SPINE ANTERIOR STABILIS.
• Type of Device: SPINE SURGERY
• 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: 15028671
• MDR Text Key: 302246075
• Report Number: 9610612-2022-00205
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-SP42
• Device Catalogue Number: AE-QAS-SP42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• 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