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

Model Number 25-010-20-09

Device Problem Break (1069)

Patient Problem Hematoma (1884)

Event Date 11/15/2016

Event Type  Injury  

Event 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.

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
• Type of Device: MESH
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 6147398
• MDR Text Key: 61514499
• Report Number: 9610905-2016-00044
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118035776
• UDI-Public: (01)00888118035776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Model Number: 25-010-20-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR