MAUDE Adverse Event Report: AESCULAP AG AESCULAP010 IMPLANTS/DISPOSABLES ANTERIOR

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that there was an issue with a unknown device manufactured by aesculap ag. According to the complainant, the surgeon reported an adverse event without details about the issue. The type of the indication was an total disc replacement. Although requested, additional information has not been made available. The adverse event / malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2021-00542 (article number unknown- aesculap surgical instruments). 9610612-2021-00562 (article number unknown- aesculap surgical instruments). 9610612-2021-00563 (article number unknown- aesculap surgical instruments).

• Brand Name: AESCULAP010
• Type of Device: IMPLANTS/DISPOSABLES ANTERIOR
• 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: 12333524
• MDR Text Key: 266966098
• Report Number: 9610612-2021-00562
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/17/2021 Patient Sequence Number: 1