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

Model Number AE-QAS-SP42

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that there was an issue with an unknown activl device.The information was made available via an ess surgeon survery; this was recorded from the time period (b)(6) 2020 to (b)(6) 2021.An unknown spinal implant was used during a total disc replacement (tdr).A "sensory neurological" adverse event occurred at the l4-l5 and l5-s1 level.Details were not further specified.Although requested, additional information had not been made available.The adverse event is filed under aag reference xc (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.

Event Description

Clarification: activl system typically involves 3 components; in this case, the 3 implants were unspecified.

Manufacturer Narrative

Additional information - b5 (clarification) investigation: 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 neither an article number nor a lot number was not provided, a review of the device history records for the complained device is not possible.Explanation and rationale: the following causes are possible: - wrong system configuration selected by the user.- wrong implant size chosen by the user.- end plate formed too strong by the user.- design layout unsuitable.- inadequate patient behavior.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: 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: 15028668
• MDR Text Key: 298875967
• Report Number: 9610612-2022-00204
• 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,Followup
• Report Date: 08/30/2022

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: 08/01/2022
• 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