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

Model Number	25-010-20-09
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that mesh was removed due to the patient's pain after a suspected fall.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.Due to no device being returned the root cause for the failure cannot be determined.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 strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7397394
• Report Number: 9610905-2018-00040
• Device Sequence Number: 173120
• Product Code: JEY
• UDI-Device Identifier: 00888118035776
• UDI-Public: (01)00888118035776
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K944565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018
• Report Date (Section F): 03/20/2018

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: Physician
• Device Model Number: 25-010-20-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 66 YR