MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS SPINE ANTERIOR STABILIS.; IMPLANTS/DISPOSABLES ANTERIOR

Model Number AE-QAS-SP42

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 08/02/2021

Event Type  malfunction  

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 ae-qas-sp42 - collect.No.Qas spine anterior stabilis.According to the complaint description, there was an issue with active implant post surgery.The original procedure was a lumbar total disc arthroplasty of l5-s1 in (b)(6) 2020.The patient is still having occasional neuropathy and mild low back pain.There was a temporary impairment.The patient had repeat imaging studies due to the pain; initially the implant positioning was good and other surrounding structures were normal.The patient did not experience trauma or fall.On (b)(6), results of computed tomography (ct) myelogram showed interval development of bilateral l5 pars defects and right l5 laminar fracture, without spondylolithesis the malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00580 (b)(4) - ae-qas-sp42), 9610612-2021-00576 (b)(4) - ae-qas-sp42).

Event Description

Associated medwatch-reports: 9610612-2021-00579 ((b)(6) - ae-qas-sp42), 9610612-2021-00580 ((b)(6) - ae-qas-sp42), and 9610612-2021-00576 ((b)(6) - ae-qas-sp42).

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 neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.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 investigations results a capa is not necessary.

• Brand Name: COLLECT.NO.QAS SPINE ANTERIOR STABILIS.
• 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: 12359980
• MDR Text Key: 267892671
• Report Number: 9610612-2021-00579
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male