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

Model Number	25-398-31-09
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Two plates broke in half after implantation into the patient.Patients fracture did not heal.Plates were removed on (b)(6) 2016 and replaced.
Additional Manufacturer Narrative
Methods: visual inspection, stereo microscopic inspection and process evaluation based on the lot number.Results: tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects observed.The product history device records were also reviewed based on the lot number provided, and no abnormalities were found.Assessment conclusion: the results of the investigation conclude that the root cause for breakages was due to mechanical overload on the device.If further information can be gathered that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6082918
• Report Number: 9610905-2016-00041
• Device Sequence Number: 13520761
• Product Code: JEY
• UDI-Device Identifier: 00888118039750
• UDI-Public: (01)00888118039750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/26/2016

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: 25-398-31-09
• Device Lot Number: 32794064
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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; Required Intervention
• Patient Age: 52 YR