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

Model Number AE-QAS-SP42

Device Problem Migration (4003)

Patient Problems Erosion (1750); Joint Disorder (2373)

Event Date 06/08/2020

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 collect.No.Qas spine.According to the customer description, it was reported that the revision surgery is scheduled for (b)(6) 2020.After a total disc replacement (tdr), there was anterior migration of the implant 6 months postoperatively.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00228 ((b)(4) ae-qas-sp42), 9610612-2020-00403 ((b)(4) collect.No.Qas spine anterior stabilis).

Manufacturer Narrative

Investigation results: the devices were not available for investigation.Therefore neither the article code nor a lot number was provided.A review of the device history records must remain incomplete due to a lack of information.As well a definitive root cause cannot be determined due to the same circumstances.A investigation was not possible without a article return or further information.

Event Description

Associated medwatch-reports: 9610612-2020-00228 (400474862) 9610612-2020-00404 (400480755) 9610612-2020-00403 (400480756).

• 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
• MDR Report Key: 10445620
• MDR Text Key: 207348204
• Report Number: 9610612-2020-00404
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention