MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE NEURO; MESH

Model Number	25-007-14-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported a portion of the implant was removed due to patient condition.
Additional Manufacturer Narrative
An investigation could not be performed because no device was returned, and no failure was described.Review of the device history records was not possible due to no lot number being identified.The root cause cannot be determined due to no device returned and no failure described.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE NEURO
• Common Device Name: MESH
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8451899
• Report Number: 9610905-2019-00086
• Device Sequence Number: 10822983
• Product Code: JEY
• UDI-Device Identifier: 00888118035424
• UDI-Public: (01)00888118035424
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K944565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2019
• Report Date (Section F): 03/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 25-007-14-09
• Device Lot Number: 33262833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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: Other
• Patient Age: 65 YR