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

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to aesculap inc., via the annual activl enhanced safety surveillance study (ess) covering a reporting period from 01feb2023 to 31dec2023, that an unknown activ l device was implanted on an unspecified date at the l4-l5 level.According to the complainant the patient experienced a sensory neurological event at the l4-l5 and l5-s1 level on an unspecified date.The adverse event is filed under aic reference (b)(4).2916714-2024-00049, 2916714-2024-00051.

Manufacturer Narrative

Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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
• MDR Report Key: 18902724
• MDR Text Key: 337645226
• Report Number: 2916714-2024-00050
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2024
• Distributor Facility Aware Date: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability