MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE NEURO 3D MESH

Model Number	25-010-20-09
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was being treated for a hematoma.Mesh was discovered broken after a mri procedure.Product was explanted and replaced with new plate and screws.Doctor stated the product breakage was due to patient being noncompliant.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscope inspection of the mesh returned.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects.The device history records could not be reviewed since no lot number was provided.The results of the investigation conclude that the root cause for the breakages were due to mechanical overload on the device.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 3D MESH
• Common Device Name: MESH
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6147398
• Report Number: 9610905-2016-00044
• Device Sequence Number: 415751
• Product Code: JEY
• UDI-Device Identifier: 00888118035776
• UDI-Public: (01)00888118035776
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K944565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2016

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?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 03/03/2017
• 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: 52 YR