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 l5-s1 level.According to the complainant the patient experienced a sensory neurological event at the l5-s1 level on an unspecified date.Reportedly there was minor numbness in a radicular distribution that resolved spontaneously in a few weeks with time, gabapentin and a medrol dose pack the adverse event is filed under aic reference (b)(4).2916714-2024-00061, 2916714-2024-00063.

• 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: 18903063
• MDR Text Key: 337650602
• Report Number: 2916714-2024-00062
• 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: 505
• 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
• Was Device Available for Evaluation?: No
• 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): Other