MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV FEM.SPACER DIST.F5 10MM; AUGMENTATION IMPLANTS COLUMBUS

Model Number	NR475Z
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Implant Pain (4561)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a as columbus rev fem.Spacer dist.F5 10mm (part#: nr475z) was implanted on (b)(6) 2023.According to the complainant the patient was infected and required a revision procedure.Reportedly the revision was performed on (b)(6) 2024.No further complications were reported as a result of the revision.The adverse event is filed under aic reference: (b)(4).Associated medwatch reports: 2916714-2024-00162 (aic reference no.(b)(4), 2916714-2024-00165 (aic reference no.(b)(4), 2916714-2024-00166 (aic reference no.(b)(4), 2916714-2024-00167 (aic reference no.(b)(4), 2916714-2024-00168 (aic reference no.(b)(4), 2916714-2024-00169 (aic reference no.(b)(4), 2916714-2024-00172 (aic reference no.(b)(4), 2916714-2024-00173 (aic reference no.(b)(4), 2916714-2024-00174 (aic reference no.(b)(4), 2916714-2024-00175 (aic reference no.(b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: 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.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: AS COLUMBUS REV FEM.SPACER DIST.F5 10MM
• Common Device Name: AUGMENTATION IMPLANTS COLUMBUS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20561231
• Report Number: 2916714-2024-00171
• Device Sequence Number: 18364261
• Product Code: JWH
• UDI-Device Identifier: 04046963177256
• UDI-Public: (01)04046963177256(11)220708(17)320707(10)52775682
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024
• Report Date (Section F): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NR475Z
• Device Catalogue Number: NR475Z
• Device Lot Number: 52775682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2024
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/29/2024